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COOK INC REDO SINGLE LUMEN TPN CATHETER SET; FOZ CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS
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| Model Number N/A |
| Device Problem
Partial Blockage (1065)
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| Patient Problems
Unspecified Infection (1930); Skin Irritation (2076); Impaired Healing (2378); No Code Available (3191)
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Event Type
Injury
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Manufacturer Narrative
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(b)(6).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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It was reported that a foreign body was found in the proximal end of the lumen of a redo single lumen tpn catheter after tpn placement.This catheter was originally placed on (b)(6) 2017.The catheter has been damaged in the past, so a first repair was performed on (b)(6) 2018 and a second repair was performed on (b)(6) 2019.After the second repair of the catheter, no force was exerted on the catheter.The patient had since been complaining about irritation at the incision site, so an abdominal x-ray was performed.They were able to see a "rod" at the site of the first repair, but they also noticed another obstruction on the image at the insertion site into the skin, of which they are not sure what it is.The "hard rod", which is positioned flat at the insertion site, seems to cause local irriation as well as the development of granulation tissue.The granulation has been treated with silver nitrate but they don't think they will be able to treat the local irritation as they view it as "this 'rod' continues to exert pressure at the site".It has also been noticed that the "rod" seems to move inside the catheter, as x-rays from may and december show it in different places.This obstruction has not impaired lumen functionality as they are still able to administer and sample through the catheter.Additional notes indicated that a dilator was used prior to catheter advancement.The placement site was the percutaneous translumbal puncture of the vena cava inferior from the right site of the body.The patient is allergic to tegaderm dressing and has had multiple catheters placed in the past.The fluids being infused through the line are as follows: -nacl 0.9%, 1000ml, 1x /week.-nacl 0.9%, 1000ml + 40meq kcl, 2x /week.-nacl 0.9%, 1000ml + 3g mgso4, 2x /week.-nahco3 1.4%, 500ml, 1x/week.-taurosept 2% to lock the catheter if not in use -during the last hospitalization, antibiotics (systemic and locksolution) were also administered for the local infection on the insertion site.The maintenance protocol of the catheter is as follows: -transparent dressing (mepitel film- anti allergic): 1x/week, or change dressing if loose, dirty or wet (protocol before the local infection problem started).-since local infection: daily use of nacl 0.9% to clean, braunol to disinfect the insertion site and cover with cosmopore dressing (because of leakage).-10ml of nacl 0.9% to flush pulsatile the catheter after deconnecting the iv bags.-after flushing, the catheter was locked with 1.5ml taurosept.No other adverse effects have been reported for this incident.
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Event Description
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Additional information was received on 20dec2019 stating that the patient underwent an additional procedure in which the complaint device was removed and replaced with an additional catheter.The radiologist tried to exchange the complaint catheter over the guidewire in order to avoid making a new puncture.As the guidewire was being pushed through the catheter, resistance was felt.The radiologist then decided to cut the catheter into pieces to aid in insertion of the guidewire.The first cut was made on the portion of the catheter external to the patient, and included the first repair.They then tried to push the guidewire through and felt resistance again.The catheter was withdrawn from the patient and the second cut was made after the location of the foreign body, referred to as a "metal rod".This location was confirmed on radiography.After the second cut the guidewire was able to be pushed up into the rest of the catheter.The last portion of the complaint catheter was removed and a new one was successfully introduced.It was reported that the "metal rod was further migrated to the catheter tip during the procedure, due to manipulation with the guidewire" and can be felt in the catheter.
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Manufacturer Narrative
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Correction: h6 - patient code.H6 - patient code: no code available (3191) - an additional procedure was performed in which the complaint device was removed and replaced with another catheter.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.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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Manufacturer Narrative
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Blank fields on this form indicate the information is unchanged, unknown or unavailable.D10 - concomitant products: the rpn and lot # of one of the repair kits used on the patient were provided.Rpn: c rhcs 6.5; lot#: 8782748.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.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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Additional information was received on 02mar2020 regarding the rpn and lot # of a repair kit used.Additionally, no problems were reported to be noticed during the repairs of the catheters.After the first repair of the catheter at uz gent, the female patient came for a check up at uz leuven.It was reported that "everything looked fine, catheter was functional".
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Manufacturer Narrative
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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.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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Additional information was received on 10feb2020 clarifying the sequence of events.The catheter was first repaired on (b)(6) 2018 at (b)(6).The patient followed up at (b)(6).The catheter was again damaged on (b)(6) 2019 and repaired in (b)(6).The first repair was completely removed.A third repair of the catheter was performed on 28nov219 at (b)(6), the previous repair was completely removed.
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Event Description
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No additional patient/event information has been received since the previous medwatch report was sent.
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Manufacturer Narrative
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Investigation ¿ evaluation: it was reported by a nurse from the catheter team that a foreign body was found in the proximal end of the lumen of a redo single lumen tpn catheter.This catheter was originally placed on (b)(6) 2017, using a dilator, via right trans-lumbar puncture of the inferior vena cava (ivc).Limited patient information was provided.The patient has had multiple catheters placed in the past including multiple totally implantable vascular access devices (tivad), tunneled catheters and midline catheters.Based on the information regarding devices placed and the current access site it is likely that the patient had difficult vascular access.The complaint device was reported to be a redo single lumen tpn catheter set (rpn: c-tpns-6.5-90-redo, lot number unknown).The placement site of the catheter was the trans lumbar puncture of the vena cava on the right side of the body using ¿xperguide.The ¿xperguide¿ is imaging software that allows the operator to obtain an intraprocedural computed tomography.On (b)(6) 2018 the catheter was repaired at uz gent.The part number of the product used for the first repair is unknown.The patient followed up at uz leuven after the repair.No additional information was provided regarding the follow up at uz leuven.The catheter was again damaged on (b)(6) 2019 and repaired at uz leuven.It was reported that the first repair was completely removed.The catheter was repaired for a second time using a cook tpn single lumen catheter repair set (rpn:c-rhcs-6.5, lot number 8782748).An x-ray was performed in (b)(6) 2019 and a ¿hard, metal rod¿ was seen on the image.The hard metal rod was reported to be ¿positioned to the left relative to the 2 balls.¿ the ¿2 balls¿ the customer referenced are the circumferential suture rings that allow the catheter to be secured to the skin with suture during tissue in-growth into the cuff.A third repair of the catheter was performed on (b)(6) 2019 at uz leuven.The previous repair was completely removed.A new repair was completed.The rpn of the repair product used was not provided.An x-ray was performed at uz leuven on (b)(6) 2019.This x-ray was performed as a result of the patient¿s complaint of irritation at the incision site.A still photo of the x-ray was provided by the customer.This x-ray showed a previous tpn catheter repair.However, it also showed where the previously identified metal rod had migrated and were ¿positioned right relative to the two balls¿ (circumferential suture rings).It was reported that the ¿foreign body/metal rod¿ was moving inside the catheter.It was reported that the device was still functional, smooth infusion of medications and smooth blood aspiration.The patient was treated with silver nitrate to address the formation of granulation tissue at the insertion site.The patient received a new trans lumbar catheter on (b)(6) 2019.The catheter was introduced over the wire to avoid a difficult puncture of the vena cava inferior.As the guidewire was being pushed through the existing catheter, resistance was felt.The radiologist then decided to cut the catheter into pieces to aid in insertion of the guidewire.The first cut was made on the portion of the catheter external to the patient, after the repair.Again, resistance was encountered upon attempted advancement of the guidewire.The catheter was withdrawn from the patient and the second cut was made after the location of the foreign body, referred to as a "metal rod.¿ the last portion of the complaint catheter was removed and a new one was successfully introduced.It was reported that the "metal rod was further migrated to the catheter tip during the procedure, due to manipulation with the guidewire" and can be felt in the catheter.A review of the complaint history, device history record, drawing, instructions for use (ifu), quality control and specifications, as well as a visual inspection of the returned device were conducted during the investigation.The visual inspection of the complaint device noted the device was returned separated into 3 segments.A wire was able to pass through all segments of the device, tightly through the proximal segment and smoothly through the other two.The foreign body referenced in the complaint did not exit any of the 3 segments.The wing hub of the device has separated.Additionally, a document based investigation evaluation was performed.A review of the device master record found that proper procedures are in place to identify and prevent this failure mode prior to device distribution.A review of the device history record found no nonconformances or additional complaints related to the second tpn repair kit used.No review of the dhr could be executed for the tpn catheter and first repair kit as the lot number is unknown.There is no evidence to suggest there is any nonconforming product in house or out in the field.A review of the product labeling for the device was completed.The current ifu for this redo single lumen tpn catheter set includes the following precaution "extreme caution must be used in placement and monitoring".The current ifu for the repair kit (c_t_irhc_rev3) includes the following instructions.1.Prepare the area.Firmly clamp catheter near its entrance to the skin with rubber-shod forceps.2.Cut off the damaged portion of the catheter.3.The replacement catheter has a preloaded metal cannula.(fig.1) apply adhesive to the metal cannula.4.Insert the metal cannula into the existing catheter lumen with a twisting motion (fig, 3) 5.Slide the existing catheter over the metal cannula until it is flush with the replacement catheter tubing (fig.4) 6.Apply adhesive to the junction (fig 5).7.Slide the sleeve over the junction.(fig.6).8.Inject adhesive into both ends of the sleeve (fig.7) and wipe off the excess adhesive based on the information provided, inspection of the returned product, and the results of the investigation, a definitive cause was not established.Cook is unable to rule out medical procedure or product failure as a cause of this event.The appropriate personnel have been notified.Per the quality engineering risk assessment, no further action is required.Cook will continue to monitor for similar complaints.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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