MAUDE Adverse Event Report: COOK INC ATB ADVANCE BALLOON CATHETER; DQY CATHETER, PERCUTANEOUS

Model Number N/A

Device Problems Balloon rupture (1049); Material Rupture (1546)

Patient Problems Foreign body, removal of (2365); Surgical procedure, additional (2564); No Code Available (3191)

Event Date 05/27/2015

Event Type  Injury  

Event Description

After placement of the pta balloon in a (b)(6) female patient's dialysis fistula, upon removal it was noted to be shredded and damaged.A larger access had to be created to advance a snare to retrieve the balloon pieces.Stitches were required on her arm due to larger access.A section of the device did not remain inside the patient's body.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.

Manufacturer Narrative

(b)(4).The event is currently under investigation.

Manufacturer Narrative

(b)(4).Event evaluation: a review of complaint history, documentation, instructions for use (ifu), quality control, specifications, trends and a visual examination of the returned product was conducted during the investigation.The visual examination of the returned, used and damaged atb catheter, along with an unspecified wire guide revealed that the device was returned in three pieces.The first piece consisted of the majority of the catheter and balloon, but the distal piece of the balloon, distal shaft (shaft underneath the balloon), and tip of the catheter were missing from this piece.The second piece consisted of the shaft that was underneath the balloon.The third piece consisted of the distal piece of the balloon, and distal catheter tip, which were on the unspecified wire guide.Piece 1: the balloon appeared scrunched, with a portion of the balloon that folds inward, and had a circumferential tear.The total balloon including the balloon bond measured 3.4 cm in length, and was estimated to measure approximately 2.4 cm in length from where a marker band would typically be on the product.However, due to the scrunching, the length is likely somewhat longer than the 3.4 and 2.4 cm measurements.Piece 2: the shaft measured approximately 13.1 cm in length and had one marker band still attached.Due to the length, it is clear that the shaft under the balloon was severely stretched as the distal between marker bands should be 4 cm.The end opposite of the marker band appeared to have accordioned indicating it had stretched and collapsed back on itself, creating a ridged or accordion-like area.It is believed that the side which accordioned; is the distal end of the shaft and it did not contain a marker band, and the second marker band was found on piece 3.Piece 3: the wire guide measured 0.0335" in diameter and was kinked in multiple locations.It is unclear if the kinking occurred during use, or during shipment to cook's facility for investigation.The wire guide was extremely kinked and curled near the distal end where the catheter tip and balloon material was still connected to the guide.The second marker band was present on the wire guide, under the balloon portion but was not attached to the shaft as wire guide was visible before and after the marker band.The marker band appeared to be kinked/crimped in place on the wire guide.The distal piece of the balloon was also severely scrunched, and had both a linear and circumferential tear.Part of the balloon appeared to have folded back on itself (like an inside-out umbrella) during attempted removal.The balloon measured approximately.5 cm in length, but is likely longer as it was folded back on itself and scrunched.The device is supplied with ifu which lists the proper indications, warnings, precautions, contraindications, and proper usage techniques including inflation/deflation and device removal methods.The rated burst pressure (rbp) is listed on the ifu and the labeling.For this specific device, the nominal pressure is 5 atm/bar and the rbp is 14 atm/bar.The ifu states, "do not exceed rated burst pressure.Rupture of balloon may occur.Adhere to balloon inflation pressure parameters in fig.1.Over-inflation may cause rupture of the balloon, with resultant damage to the vessel wall.Use of a pressure gauge is recommended to monitor inflation pressures." the ifu also states, "if balloon pressure is lost and/or balloon rupture occurs, deflate balloon and remove balloon and sheath as a unit." the ifu states the following for balloon deflation and withdrawal, "1.Completely deflate the balloon using an inflation device or syringe.2.Deflate the balloon by pulling vacuum on the inflation syringe or inflation device.Maintain vacuum on the balloon and withdraw the catheter.Upon catheter withdrawal, a gentle counterclockwise rotation of the catheter will assist balloon rewrap, minimizing trauma to the percutaneous entry site.3.If resistance is met during withdrawal, apply a negative pressure with a larger syringe before proceeding.If resistance continues, remove balloon and sheath as a unit." although the user did not report a balloon rupture, visual inspection was indicative of a balloon rupture.The inflation pressure was not reported by the user.The device appeared to have either burst circumferentially and may have tore linearly on the distal piece of the balloon during difficult removal (when the balloon folded back on itself), or the device may have burst first burst linearly and then turned to a circumferential burst at a point of calcification or may have tore circumferentially upon difficult removal.The user did not report how withdrawal was attempted (i.E.Through a sheath, removed with sheath as a unit, etc.).If the balloon did burst and the device was attempted to be withdrawn through a sheath, the sheath/introducer could have aided in the difficult removal and subsequent separation as balloon rewrap would be very difficult through a sheath.If balloon burst did not occur, then withdrawal through a sheath may be attempted but the user should withdrawal the device with counterclockwise rotation to aid in rewrap.If this did not occur and withdrawal was attempted through a sheath, the user may experience resistance in which case the ifu instructs the user to remove the catheter and sheath as a unit.Without additional information, it is difficult to determine a definitive root cause.Based on visual inspection, the device indicates that the balloon ruptured.Per quality engineering risk assessment, there is insufficient risk to warrant risk reduction activities.We have notified the appropriate internal personnel and will continue to monitor for similar complaints.A.4) (b)(4).Event evaluation: a review of complaint history, documentation, instructions for use (ifu), quality control, specifications, trends and a visual examination of the returned product was conducted during the investigation.The visual examination of the returned, used and damaged atb catheter, along with an unspecified wire guide revealed that the device was returned in three pieces.The first piece consisted of the majority of the catheter and balloon, but the distal piece of the balloon, distal shaft (shaft underneath the balloon), and tip of the catheter were missing from this piece.The second piece consisted of the shaft that was underneath the balloon.The third piece consisted of the distal piece of the balloon, and distal catheter tip, which were on the unspecified wire guide.Piece 1: the balloon appeared scrunched, with a portion of the balloon that folds inward, and had a circumferential tear.The total balloon including the balloon bond measured 3.4 cm in length, and was estimated to measure approximately 2.4 cm in length from where a marker band would typically be on the product.However, due to the scrunching, the length is likely somewhat longer than the 3.4 and 2.4 cm measurements.Piece 2: the shaft measured approximately 13.1 cm in length and had one marker band still attached.Due to the length, it is clear that the shaft under the balloon was severely stretched as the distal between marker bands should be 4 cm.The end opposite of the marker band appeared to have accordioned indicating it had stretched and collapsed back on itself, creating a ridged or accordion-like area.It is believed that the side which accordioned; is the distal end of the shaft and it did not contain a marker band, and the second marker band was found on piece 3.Piece 3: the wire guide measured 0.0335" in diameter and was kinked in multiple locations.It is unclear if the kinking occurred during use, or during shipment to cook's facility for investigation.The wire guide was extremely kinked and curled near the distal end where the catheter tip and balloon material was still connected to the guide.The second marker band was present on the wire guide, under the balloon portion but was not attached to the shaft as wire guide was visible before and after the marker band.The marker band appeared to be kinked/crimped in place on the wire guide.The distal piece of the balloon was also severely scrunched, and had both a linear and circumferential tear.Part of the balloon appeared to have folded back on itself (like an inside-out umbrella) during attempted removal.The balloon measured approximately.5 cm in length, but is likely longer as it was folded back on itself and scrunched.The device is supplied with ifu which lists the proper indications, warnings, precautions, contraindications, and proper usage techniques including inflation/deflation and device removal methods.The rated burst pressure (rbp) is listed on the ifu and the labeling.For this specific device, the nominal pressure is 5 atm/bar and the rbp is 14 atm/bar.The ifu states, "do not exceed rated burst pressure.Rupture of balloon may occur.Adhere to balloon inflation pressure parameters in fig.1.Over-inflation may cause rupture of the balloon, with resultant damage to the vessel wall.Use of a pressure gauge is recommended to monitor inflation pressures." the ifu also states, "if balloon pressure is lost and/or balloon rupture occurs, deflate balloon and remove balloon and sheath as a unit." the ifu states the following for balloon deflation and withdrawal, "1.Completely deflate the balloon using an inflation device or syringe.2.Deflate the balloon by pulling vacuum on the inflation syringe or inflation device.Maintain vacuum on the balloon and withdraw the catheter.Upon catheter withdrawal, a gentle counterclockwise rotation of the catheter will assist balloon rewrap, minimizing trauma to the percutaneous entry site.3.If resistance is met during withdrawal, apply a negative pressure with a larger syringe before proceeding.If resistance continues, remove balloon and sheath as a unit." although the user did not report a balloon rupture, visual inspection was indicative of a balloon rupture.The inflation pressure was not reported by the user.The device appeared to have either burst circumferentially and may have tore linearly on the distal piece of the balloon during difficult removal (when the balloon folded back on itself), or the device may have burst first burst linearly and then turned to a circumferential burst at a point of calcification or may have tore circumferentially upon difficult removal.The user did not report how withdrawal was attempted (i.E.Through a sheath, removed with sheath as a unit, etc.).If the balloon did burst and the device was attempted to be withdrawn through a sheath, the sheath/introducer could have aided in the difficult removal and subsequent separation as balloon rewrap would be very difficult through a sheath.If balloon burst did not occur, then withdrawal through a sheath may be attempted but the user should withdrawal the device with counterclockwise rotation to aid in rewrap.If this did not occur and withdrawal was attempted through a sheath, the user may experience resistance in which case the ifu instructs the user to remove the catheter and sheath as a unit.Without additional information, it is difficult to determine a definitive root cause.Based on visual inspection, the device indicates that the balloon ruptured.Per quality engineering risk assessment, there is insufficient risk to warrant risk reduction activities.We have notified the appropriate internal personnel and will continue to monitor for similar complaints.

Event Description

After placement of the pta balloon in a (b)(6) female patient's dialysis fistula, upon removal it was noted to be shredded and damaged.A larger access had to be created to advance a snare to retrieve the balloon pieces.Stitches were required on her arm due to the larger access.A section of the device did not remain inside the patient's body.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.

• Brand Name: ATB ADVANCE BALLOON CATHETER
• Type of Device: DQY CATHETER, PERCUTANEOUS
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: larry pool ; 750 daniels way; bloomington, IN 47404 ; 8128294891
• MDR Report Key: 4875026
• MDR Text Key: 6043627
• Report Number: 1820334-2015-00385
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K033875
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/28/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/25/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/12/2017
• Device Model Number: N/A
• Device Catalogue Number: ATB5-35-80-10-4.0
• Device Lot Number: 5648527
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/11/2015
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 05/27/2015
• Device Age: 3 MO
• Event Location: Hospital
• Date Manufacturer Received: 06/03/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/12/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 57 YR