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

Model Number	G52359
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/23/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Name and address: mobile: (b)(6).This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.
Event or Problem Description
As reported, during a thoracic endovascular aneurysm repair procedure, an advance 35 lp low profile balloon catheter ruptured.The balloon catheter was used for pre-dilation, prior to placing a stent graft.The device was inflated once to 8 atmospheres, using an unknown inflation device and solution, when the rupture occurred.The balloon was not inflated within a stent.The device was removed by itself, and another device of the same type was used to complete the procedure.No adverse effects to the patient were reported.
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
Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Event summary: as reported, during a thoracic endovascular aneurysm repair procedure, an advance 35 lp low profile balloon catheter ruptured.The balloon catheter was used for pre-dilation, prior to placing a stent graft.The device was inflated once to 8 atmospheres, using an unknown inflation device and solution, when the rupture occurred.The balloon was not inflated within a stent.The device was removed by itself, and another device of the same type was used to complete the procedure.No adverse effects to the patient were reported.Additional information: h6 (annex g).Investigation - evaluation.Reviews of the complaint history, device history record, drawing, specifications, instructions for use, and quality control procedures of the device were conducted during the investigation.No device was returned for investigation.A document-based investigation evaluation was performed.No related non-conformances were recorded, and there have been no other reported complaints for this lot number.The device history record review provides objective evidence that the device was manufactured to specification.There is no evidence of nonconforming devices from the complaint lot in house or in the field.The device is provided with instructions for use which warn, ¿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, which resultant damage to the vessel wall.Use of a pressure gauge is recommended to monitor inflation pressures.¿ the ifu further states, ¿note: if resistance is met while advancing the balloon dilatation catheter, determine the cause and proceed with caution.¿ based on the available information, cook has concluded that a manufacturing and quality control deficiency contributed to this failure mode.A previous capa investigation determined that inadequate preventive maintenance of folding equipment, inadequate process controls for folding and bonding processes, and inadequate qc work instructions for inspection microtears were the root causes of this failure mode.Corrective actions were implemented to address these root causes after the reported lot for this complaint was manufactured.Cook will continue monitoring of similar complaints and has notified the appropriate personnel of this event.Per the quality engineering risk assessment, no further action is required.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: 12752463
• Report Number: 1820334-2021-02442
• Device Sequence Number: 20027396
• Product Code: DQY
• UDI-Device Identifier: 10827002523590
• UDI-Public: (01)10827002523590(17)220806(10)9930054
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 02/25/2022

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: 08/06/2022
• Device Model Number: G52359
• Device Catalogue Number: PTA5-35-80-8-4.0
• Device Lot Number: 9930054
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/25/2021
• Supplement Date Received by Manufacturer: 02/23/2022
• Initial Report FDA Received Date: 11/04/2021
• Supplement Report FDA Received Date: 02/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/06/2019
• 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: GORE/DRY SHEATH; GORE/DRY SHEATH
• Patient Sex: Unknown