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

Catalog Number	PTA5-35-80-12-8.0
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); No Code Available (3191)
Date of Event	03/26/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Per the initial reporter, the device will not be returned.(b)(4).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
It was reported that the advance 35 low profile balloon catheter burst circumferentially at 8 atmospheres(atm) while being inflated over another manufacturer's guidewire.The event occurred during an unspecified fistula repair procedure.The patient was taken to surgery to retrieve the balloon fragments.Additional information regarding event details, patient anatomy and outcome has been requested, but is not available at this time.
Event or Problem Description
No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.Refer to section h10 for investigational findings.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Investigation - evaluation.A review of the complaint history, device history record, instructions for use (ifu), and a photographic examination of the complaint device were conducted during the investigation.The device was not returned for a physical evaluation.The complaint device was not returned; therefore, no physical examinations could be performed.However, photographs of the complaint device were returned for inspection.One image was of the proximal end of the balloon catheter, and the other image was of the distal end of the balloon catheter.Both images depicted the radial separation of the balloon as well as a separation of the catheter tubing under the balloon.Additionally, a document based investigation evaluation was performed.There is no evidence to suggest the product was not made to specifications.A review of the device history record shows no nonconforming events which could contribute to this failure mode.It should be noted there were no other reported complaints for this lot number.Based on the information provided, no product returned and the results of our investigation, a definitive root cause could not be determined.Measures are being conducted to address this failure mode.We will continue to monitor for similar complaints.Per the quality engineering risk assessment, no further action is required.This report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or 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
• MDR Report Key: 7426162
• Report Number: 1820334-2018-00728
• Device Sequence Number: 1233774
• Product Code: DQY
• UDI-Device Identifier: 10827002523804
• UDI-Public: (01)10827002523804(17)200907(10)8199068
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: K091527
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/24/2018

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: PTA5-35-80-12-8.0
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/26/2018
• Supplement Date Received by Manufacturer: 07/17/2018
• Initial Report FDA Received Date: 04/12/2018
• Supplement Report FDA Received Date: 07/24/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention