MAUDE Adverse Event Report: COOK INC ADVANCE 35 LP LOW PROFILE BALLOON CATHETER; DQY CATHETER, PERCUTANEOUS

Catalog Number	PTA5-35-135-8-4.0
Medical Device Problem Codes	Break (1069); Material Rupture (1546)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	08/16/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown or unavailable.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.
Event or Problem Description
As reported, during an unspecified procedure involving a patient with stenosis of the iliac artery, an advance 35 lp low profile balloon catheter's balloon ruptured, and the balloon and catheter tip separated.An unspecified inflation device was used to inflate the balloon one time for two minutes, within an eighty-percent occluded lesion, at which point the balloon ruptured longitudinally at six atmospheres.Blood was noted in the inflation device at the time of rupture.The balloon was not inflated within a stent prior to rupturing.The anatomy was reportedly not tortuous or calcified.The balloon catheter was unable to be removed through a cook 6-french flexor sheath, despite multiple attempts to remove the balloon catheter.Negative pressure was not maintained during attempted removal, and a counterclockwise rotation of the catheter was not conducted.After the balloon and catheter separated, an incision was made in the popliteal artery, and an unspecified gooseneck snare was used to remove the fragment, ending the procedure.No part of the device remains in the patient.The procedure was prolonged, and the surgical cost increased.The user reported "increased trauma due to the popliteal artery incision".Conflicting information was provided regarding stent placement within the iliac artery.Initially, the user reported that the balloon ruptured during an inflation that took place after a stent was placed.Information later received from the customer noted that a stent was not placed.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Summary of event: as reported, during an unspecified procedure involving a patient with stenosis of the iliac artery, an advance 35 lp low profile balloon catheter's balloon ruptured, and the balloon and catheter tip separated.An unspecified inflation device was used to inflate the balloon one time for two minutes, within an eighty-percent occluded lesion, at which point the balloon ruptured longitudinally at six atmospheres.Blood was noted in the inflation device at the time of rupture.The balloon was not inflated within a stent prior to rupturing.The anatomy was reportedly not tortuous or calcified.The balloon catheter was unable to be removed through a cook 6-french flexor sheath, despite multiple attempts to remove the balloon catheter.Negative pressure was not maintained during attempted removal, and a counterclockwise rotation of the catheter was not conducted.After the balloon and catheter separated, an incision was made in the popliteal artery, and an unspecified gooseneck snare was used to remove the fragment, ending the procedure.No part of the device remains in the patient.The procedure was prolonged, and the surgical cost increased.The user reported "increased trauma due to the popliteal artery incision".Conflicting information was provided regarding stent placement within the iliac artery.Initially, the user reported that the balloon ruptured during an inflation that took place after a stent was placed.Information later received from the customer noted that a stent was not placed.Investigation evaluation: reviews of the complaint history, device history record (dhr), instructions for use (ifu), and quality control procedures were conducted during the investigation.A visual inspection of the returned device was also conducted.Physical examination of the returned device found the end of the catheter was separated, tearing the balloon in half, with the catheter segment that separated being approximately 8cm in length.Bunching of the catheter material was noted approximately 5cm from the distal point on the remaining separated portion of the catheter.A document-based investigation evaluation was performed.No related non-conformances were found, and there have been no other reported complaints for this lot number.The device instructions for use (ifu) states, ¿if resistance is met during withdrawal, apply negative pressure with a larger syringe before proceeding.If resistance continues, remove balloon and sheath as a unit.¿ the ifu also cautions ¿the catheter is not intended for the delivery of stents.¿ the ifu states ¿upon catheter withdrawal, a gentle counterclockwise rotation of the catheter will assist balloon rewrap, minimizing trauma to the percutaneous entry site.¿ the information provided upon review of the dhr, device master record (dmr), and ifu, suggests that there is evidence the device was manufactured to specification.There is no evidence of non-conforming devices in house or out in the field.Cook's review of the device master record (dmr) has concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.Based on the available information and results of the investigation, cook has concluded that a failure to follow instructions has contributed to the failure in this incident.Although it was noted that the access site had no calcification or tortuous anatomy, the balloon was inflated within an 80% occluded lesion.After the balloon ruptured, resistance was encountered during multiple attempts to remove the balloon catheter from the sheath, but the user did not maintain negative pressure and a counterclockwise rotation of the catheter was not performed to assist with rewrap as instructed in the ifu.The ifu also instructs the user to remove the balloon catheter and sheath as a unit if balloon rupture occurs and/or if resistance continues during catheter withdrawal.The risk analysis for this failure mode was reviewed and no additional escalation was required.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.
Event or Problem Description
No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.

• Brand Name: ADVANCE 35 LP LOW PROFILE BALLOON CATHETER
• Common Device Name: DQY CATHETER, PERCUTANEOUS
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer (Section G): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: jason crouch ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 17691944
• Report Number: 1820334-2023-01193
• Device Sequence Number: 20465878
• Product Code: DQY
• UDI-Device Identifier: 10827002522791
• UDI-Public: (01)10827002522791(17)250824(10)CINC001956
• Combination Product (Y/N): N
• PMA/510(K) Number: K091527
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/24/2025
• Device Catalogue Number: PTA5-35-135-8-4.0
• Device Lot Number: CINC001956
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/16/2023
• Supplement Date Received by Manufacturer: 11/28/2023
• Initial Report FDA Received Date: 09/06/2023
• Supplement Report FDA Received Date: 12/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/24/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: KCFW-6.0-38-40-RB-BLKN
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 80 YR
• Patient Sex: Female
• Patient Weight: 52 KG