| Model Number G56611 |
| Device Problem
Premature Separation (4045)
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| Patient Problem
No Consequences Or Impact To Patient (2199)
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| Event Date 02/05/2020 |
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Event Type
malfunction
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Manufacturer Narrative
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Common name & product code = nin, stent, renal.Occupation = non-healthcare professional.Pma/510(k) number = p100028.This report includes information known at this time.A follow-up report will be submitted should additional relevant information become available.
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Event Description
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As reported, during a procedure to place a stent in the superior vena cava of a pediatric patient, a formula 418 renal balloon-expandable stent came off the delivery system.This occurred as the device was being inserted into an unknown sheath via the common femoral artery.The procedure was completed with another device.A section of the device did not remain inside the patient¿s body.The patient did not require any additional procedures due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.
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Manufacturer Narrative
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Blank fields on this form indicate the information is unknown, unchanged, or unavailable.Additional information: b3, b5, d11 d11: concomitant products= cook kcfw-6.0-18/38-45-rb-anl0-hc (g44154); abbott hi torque steelcore peripheral guidewire used (abbott #1007709).This report includes information known at this time.A follow-up report will be submitted should additional relevant information become available.
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Event Description
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Additional information received 19mar2020.The insertion tool was not used.
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Event Description
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No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.
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Manufacturer Narrative
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Summary of event: as reported, during a procedure to place a stent in the superior vena cava of a pediatric patient, a formula 418 renal balloon-expandable stent came off the delivery system.This occurred as the device was being inserted into an unknown sheath via the common femoral artery.The procedure was completed with another device.The insertion tool was not used.A section of the device did not remain inside the patient¿s body.The patient did not require any additional procedures due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.Investigation evaluation: a review of the complaint history, device history record, documentation, drawing, instructions for use (ifu), manufacturing instructions, and quality control procedures was conducted during the investigation.The complaint device was not returned to cook for investigation; however, devices from another complaint involving the same lot and failure mode were found to have pillowing/indentations on the balloon, suggesting that the stent was heat set and seated in place during manufacturing of the device.A document-based investigation evaluation was performed.No related non-conformances were found.There have been two other reported complaints for this lot number.A device master record review was performed, including device specifications, drawings, manufacturing instructions, and quality control procedures.Cook has concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.The device's design history files were reviewed and showed that for the testing related to this failure, all test samples met the acceptance criteria.The work order for complaint lot 10153876 indicates that the stent crimping step for the units in this lot was performed on (b)(6) 2019.Based on a review of the calibration records, there is no evidence to suggest that the stent crimping machine or heat set station equipment impacted this issue.The product ifu states that the intended use of the device is for patients with atherosclerotic disease of the renal arteries.The ifu states: ¿special care must be taken not to handle or in any way disrupt the stent on the balloon.This is particularly important during removal of the catheter from packaging, placement over the wire guide, and through the large-bore tuohy-borst ¿y¿ adapter and guiding catheter hub.¿ the ifu also states: ¿correct guiding catheter / introducer selection and technique are necessary for use of the stent.Ensure that the inside lumen of the guiding catheter / introducer is of sufficient size to allow unobstructed passage of the formula 418 renal balloon-expandable stent system.¿ the ifu instructs: ¿if using an introducer with a valve, make sure the flared end of the insertion tool (provided in the package) is loaded over the premounted stent on the balloon catheter.¿ based on the information provided and the results of the investigation, cook has concluded that a definitive cause for the event cannot be determined; however, it was reported that the insertion tool was not used.The ifu instructs the user to use the insertion tool (provided with the device) for insertion of the stent system if an introducer with a valve is used.Corrective action measures have been initiated to investigate this further.The risk analysis for this failure mode was updated in response to this incident.The appropriate personnel have been notified and cook will continue to monitor for similar events.This report is required by the fda under 21 cfr part 803 and is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement contained herein is intended to be an admission that any cook device is defective or malfunctioned, that a death or serious injury occurred, nor that any cook device caused, contributed to, or is likely to cause or contribute to a death or serious injury if a malfunction occurred.
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Manufacturer Narrative
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Blank fields on this form indicate the information is unknown, unavailable, or unchanged.B5= two devices from events associated with patient identifiers(b)(6) (mdr 1820334-2020-00364) and (b)(6) (mdr 1820334-2020-00408) were returned to cook in the same box on 26oct2020.One device from lot 10153876 (originally reported) was returned, as well as one device from lot 10185395.There was no complaint received from the user facility associated with lot 10185395.Attempts are being made to obtain details surrounding the device from lot 10185395.Initial inspection of the device from lot 10185395 found that the stent was off the balloon catheter.A new complaint was opened to capture this device malfunction and will be reported under patient identifier (b)(6) (mdr 1820334-2020-02180).It is unknown if the device was used during the case involving patient identifier (b)(6) or (b)(6).H3: device evaluated by mfg = other (81) - it is unknown if the returned devices from lots 10153876 and 10185395 were used in the case associated with patient identifier (b)(6) (mdr 1820334-2020-00364) or (b)(6) (mdr 1820334-2020-00408).Investigation of the devices has begun; however, a conclusion is not yet available.This report includes information known at this time.A follow-up report will be submitted should additional relevant information become available.This report is required by the fda under 21 cfr part 803 and is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement contained herein is intended to be an admission that any cook device is defective or malfunctioned, that a death or serious injury occurred, nor that any cook device caused, contributed to, or is likely to cause or contribute to a death or serious injury if a malfunction occurred.
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Manufacturer Narrative
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H6: ec methods code desc - 5: communication/interviews (4111).Description of event: as reported, during a stenting procedure of the superior vena cava, two formula 418 renal balloon-expandable stents came off of the stent catheter.As the user attempted to insert each of the two stent catheters into an unknown access sheath, the stents came off of the catheters.A third device of the same type was used to complete the procedure successfully.The insertion tool was not used.Two devices from events associated with patient identifiers (b)(6) (mdr 1820334-2020-00364) and 292150 (mdr 1820334-2020-00408) were returned to cook in the same box on 26oct2020.One device from lot 10153876 (originally reported) was returned, as well as one device from lot 10185395.There was no complaint received from the user facility associated with lot 10185395.Attempts are being made to obtain details surrounding the device from lot 10185395.Initial inspection of the device from lot 10185395 found that the stent was off the balloon catheter.A new complaint was opened to capture this device malfunction and will be reported under patient identifier 315115 (mdr 1820334-2020-02180).It is unknown if the device was used during the case involving patient identifier 291815 or 292150.Investigation ¿ evaluation: a visual inspection of the returned device was conducted.A document based investigation was also performed including a review of complaint history, device history record, documentation, drawings, the instructions for use, interview personnel, manufacturing instructions, and quality control data.(b)(4), lot #10153876: one for418-18-80-6-12 balloon catheter received.No visible damage noted to the device.The stent was not present on the catheter and was not returned.Inspection of the balloon found indentations in the balloon material suggesting that the stent was heat set and crimped in place during the manufacturing of the device.It is unknown which event (complaint pr291815 or pr292150) the returned device from lot 10153876 is associated with.Although only one device returned, based on the information received from the user facility it is assumed that three devices from lot 10153876 experienced this failure mode.A review of the device history record found no non-conformances related to the reported failure mode.Because there are no related non-conformances, adequate inspection activities have been established, there is objective evidence that the dhr was fully executed, and no other lot related complaints that have been received from the field, it was concluded that there is no evidence that nonconforming product exists in house or in field.A review of complaint history records search revealed that complaints pr292150 and pr292047 are also associated with complaint lot 10153876.The instructions for use (ifu), provides the following information to the user related to the reported failure mode: device description ¿the formula renal stent is a balloon-expandable stent made of 316l stainless steel with a slotted tube configuration.It is pre-mounted on an over-the-wire balloon catheter, which serves as the delivery system (formula 418 renal balloon-expandable stent system).The stent is positioned between two radiopaque marker bands, which are located inside the balloon at the proximal distal tapers of the balloon.The cannula design of the stent provides a low outside diameter profile, which permits use with a 5.0 french sheath and a 6.0 french guiding catheter for 4-6mm diameter sizes; and a 6.0 french sheath and 7.0 french guiding catheter for the 7.0mm diameter size.The formula rental stent is premounted on 80 and 135 cm balloon catheter delivery systems.The stent is available in nominal expanded diameters of 4, 5, 6 and 7mm with lengths of 12, 16, and 20 mm each.¿ intended use ¿the formula 418 renal balloon-expandable stent system is indicated for use in patients with atherosclerotic disease of the renal arteries following suboptimal percutaneous renal angioplasty (ptra) of a de novo or restenotic lesion (= 18 mm in length) located within 10 mm of the renal ostium and with a reference vessel diameter of 4.0 ¿ 7.0 mm.Suboptimal ptra is defined as = 50% residual stenosis, = 20mmhg systolic or = 10 mmhg mean translesional pressure gradient, or flow-limiting dissection.¿ precautions ¿special care must be taken not to handle or in any way disrupt the stent on the balloon.This is particularly important during removal of the catheter from packaging, placement over the wire guide, and through the large-bore tuohy-borst ¿y¿ adapter and guiding catheter hub.¿ stent placement ¿special care must be taken not to handle or in any way disrupt the stent on the balloon.This is particularly important during removal of the catheter from packaging, placement over the wire guide, and advancement through the large-bore tuohy-borst ¿y¿ adapter and guiding catheter hub.¿ product recommendations wire guide use and selection ¿the formula 418 renal balloon-expandable stent system is compatible with 0.018 inch wire guides.¿ guiding catheter/introducer selection ¿correct guiding catheter / introducer selection and technique are necessary for use of the stent.Ensure that the inside lumen of the guiding catheter / introducer is of sufficient size to allow unobstructed passage of the formula 418 renal balloon-expandable stent system.¿ preparation of balloon catheter ¿remove the formula 418 renal balloon-expandable stent system from the package, remove protective sleeve from the distal tip of the catheter, and inspect the stent to ensure it has not been damaged.¿ ¿before inserting the formula 418 renal balloon-expandable stent system into the guiding catheter or introducer, be sure that a large-bore tuohy-borst ¿y¿ adapter or introducer valve is on the guiding catheter / introducer.¿ ¿insert the appropriate guiding catheter/introducer.¿ ¿advance the premounted formula 418 renal balloon-expandable stent system over the wire into either the introducer valve or tuohy borst ¿y¿ adapter.¿ ¿if using an introducer with a valve, make sure the flared end of the insertion tool (provided in the package) is loaded over the premounted stent on the balloon catheter.Pass the insertion tool loaded with the premounted stent through the introducer valve.Push the formula 418 renal balloon-expandable stent system into the body of the introducer.Slide the insertion tool proximally up the catheter shaft away from the guiding catheter/introducer.A slight contact of the stent with t introducer may be felt, but there must be no resistance.¿ ¿if using a tuohy-borst ¿y¿ adapter, advance the premounted formula 418 renal balloon-expandable stent system over the wire and into the fully opened large-bore tuohy-borst ¿y¿ adapter.Gently advance the formula 418 renal balloon-expandable stent system completely thought the tuouhy-borst ¿y¿ adapter and into the guiding catheter/ introducer.A slight contact of the stent with the guiding catheter/introducer may be felt, but there must be no resistance.¿ ¿warning: if resistance is encountered, do not force passage.Resistance may indicate damage to stent.¿ removal of unexpanded stent: ¿do not attempt to pull an unexpanded stent back into the guiding catheter / introducer.The formula 418 renal balloon-expandable stent system should be withdrawn until the proximal end of the stent is aligned with the distal tip of the guiding catheter / introducer.Withdraw the guiding catheter / introducer and stent delivery system as a single unit, leaving the wire guide in place.Warning: if stent is removed, do not attempt to reuse the device.Damage to the stent may occur upon removal.¿ how supplied: ¿upon removal from package, inspect the product to ensure no damage has occurred.¿ a review of relevant manufacturing documents was conducted.It was concluded that the device aspect in question was visually/functionally inspected by quality control and no related gaps in production or processing controls were noted.Cook has concluded a definitive conclusion could not be determined.It was reported that the insertion tool was not used during insertion of the complaint device into the sheath; the user¿s practice is to simply insert the product through the sheath without the aid of a tool.The ifu instructs the user to use the insertion tool (provided with the device) for insertion of the stent system if an introducer with a valve is used.A capa has been opened to further investigate this failure mode.Per the quality engineering risk assessment, no further action is warranted.Cook will continue to monitor this device via the complaints database for similar complaints.This report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.
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Event Description
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No new patient or event information to report.
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Search Alerts/Recalls
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