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

Catalog Number PTA5-35-135-10-4.0

Device Problem Material Rupture (1546)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/02/2024

Event Type  Injury  

Manufacturer Narrative

H3: device evaluated by mfg = other (81) - device evaluation 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.

Event Description

As reported, during a procedure involving balloon dilation of a stent in the iliac artery, an advance 35 lp low profile balloon catheter's balloon ruptured.The anatomy was severely calcified, and both iliac arteries were stenosed and greater than fifty percent occluded.The balloon was used to deliver and initially expand another manufacturer's stent.Another manufacturer's pressure pump/inflation device was used to inflate the balloon two times to eight atmospheres, for thirty seconds each time, to expand the stent; however, the balloon ruptured circumferentially during posterior expansion of the stent.Blood was not noted in the inflation device.It was reportedly then impossible to remove the balloon catheter through another manufacturer's sheath, and the customer cut the balloon off during the "extraction process".The balloon was removed via an incision of the right femoral artery.It is unknown if a counter-clockwise rotation of the catheter was conducted upon attempted removal of the device or if the balloon returned to ambient pressure; however, negative pressure was maintained upon attempted removal of the balloon catheter.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.

• Brand Name: ADVANCE 35 LP LOW PROFILE BALLOON CATHETER
• Type of Device: 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: 18908581
• MDR Text Key: 337731584
• Report Number: 1820334-2024-00351
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 10827002522937
• UDI-Public: (01)10827002522937(17)251102(10)CINC002306
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K091527
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/14/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: PTA5-35-135-10-4.0
• Device Lot Number: CINC002306
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/13/2024
• Date Manufacturer Received: 02/23/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/02/2022
• 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
• Treatment: DIMAC PRESSURE PUMP; EV3 GP3 STENT 10X4, 12X4; TERUMO 6FR SHEATH
• Patient Outcome(s): Required Intervention
• Patient Age: 60 YR
• Patient Sex: Male