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

Model Number	G52344
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/16/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Address: (b)(6).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, an advance 35 lp low profile balloon catheter's balloon ruptured upon the first inflation.An unspecified inflation device was used to inflate the balloon one time to an unknown pressure, within a severely calcified, ninety percent stenosed lesion within the iliac artery.The balloon was not inflated within a stent prior to rupturing.The device was removed by itself, and another balloon of the same type was used to complete the procedure.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unchanged, or unavailable.Summary of event: as reported, during an unspecified procedure, an advance 35 lp low profile balloon catheter's balloon ruptured upon the first inflation.An unspecified inflation device was used to inflate the balloon one time to an unknown pressure, within a severely calcified, ninety percent stenosed lesion within the iliac artery.The balloon was not inflated within a stent prior to rupturing.The device was removed by itself, and another balloon of the same type was used to complete the procedure.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, documentation, drawing, instructions for use (ifu), specifications, and quality control procedures were conducted during the investigation.The complaint device was not returned to cook for investigation.A document-based investigation evaluation was performed.No related non-conformances or additional complaints were found on the final lot.One relevant non-conformance was noted on a subassembly lot; however, all affected product was scrapped and not replaced.The non-conformance was investigated by internal personnel at the time the non-conformance was recorded, and the supplier of the affected material was notified.A search of complaint history found no additional complaints involving the subassembly lot.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.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 pressure." the ifu further cautions, "in heavily scarred access sites, use of an introducer sheath is recommended." the information provided upon review of the dmr, dhr, and ifu suggests that there is evidence the device was manufactured to specification.Although one relevant non-conformance was noted on a sub-assembly lot, all non-conforming product was scrapped, there are 100% inspections in place to capture this non-conformance, adequate inspection activities have been established, there is objective evidence that the dhr was fully executed, and no other lot-related complaints have been received from the field.Therefore, it was concluded that there is no evidence of non-conforming devices in-house or in the field.Cook has concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.Based on the information provided and the results of the investigation, cook has concluded that the patient¿s severely calcified and stenosed anatomy contributed to this event.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: 16620159
• Report Number: 1820334-2023-00316
• Device Sequence Number: 20381813
• Product Code: DQY
• UDI-Device Identifier: 10827002523446
• UDI-Public: (01)10827002523446(17)240419(10)13900905
• 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,Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/19/2024
• Device Model Number: G52344
• Device Catalogue Number: PTA5-35-80-6-2.0
• Device Lot Number: 13900905
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/17/2023
• Supplement Date Received by Manufacturer: 08/18/2023
• Initial Report FDA Received Date: 03/27/2023
• Supplement Report FDA Received Date: 09/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/19/2021
• 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: TERUMO DESTINATION 6FR SHEATH.
• Patient Sex: Unknown