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

Catalog Number	PTA5-35-135-10-4.0
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/02/2024
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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.
Event or Problem Description
No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.
Additional Manufacturer Narrative
Summary of event: 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.Investigation evaluation: reviews of the complaint history, device history record (dhr), instructions for use (ifu), manufacturing instructions, and quality control procedures were conducted during the investigation.A visual inspection of the complaint device was also conducted.The used complaint device was returned to cook for investigation.The shaft was separated from the strain relief.Due to balloon damage, a leak test could not be performed.A document-based investigation evaluation was performed.A review of the device history record found no relevant non-conformances on the lot.A review of complaint history found no additional complaints for this lot number.The product ifu warns ¿do not exceed rated burst pressure.Rupture of balloon may occur.Adhere to balloon inflation pressure parameters in the compliance card insert.¿ the ifu also cautions ¿the catheter is not intended for the delivery of stents.¿ a review of the device master record (dmr) concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.The information provided upon review of the dmr, dhr, ifu, and investigation of the returned device suggests that there is evidence the device was manufactured to specification.There is no evidence of non-conforming devices in-house or in the field.Based on the information provided and the results of the investigation, cook has concluded that unintended user error and the patient¿s anatomy likely contributed to this event.The anatomy was very calcified, and the iliac arteries were more than fifty percent occluded.The balloon was used for delivery and expansion of another manufacturer¿s stent.The ifu specifically cautions that the balloon is not intended for the delivery of stents.The ifu also instructs the user to remove the balloon catheter and sheath as a unit if rupture occurs.In this case, the user attempted to remove the balloon catheter through another manufacturer¿s sheath after the balloon ruptured.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.

• 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: 18908581
• Report Number: 1820334-2024-00351
• Device Sequence Number: 7514939
• Product Code: DQY
• UDI-Device Identifier: 10827002522937
• UDI-Public: (01)10827002522937(17)251102(10)CINC002306
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K091527
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/03/2024

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: 11/02/2025
• 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
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/23/2024
• Supplement Date Received by Manufacturer: 05/06/2024
• Initial Report FDA Received Date: 03/14/2024
• Supplement Report FDA Received Date: 06/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/02/2022
• 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: DIMAC PRESSURE PUMP; EV3 GP3 STENT 10X4, 12X4; TERUMO 6FR SHEATH
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 60 YR
• Patient Sex: Male