MAUDE Adverse Event Report: COOK INC ATB ADVANCE BALLOON CATHETER; DQY CATHETER, PERCUTANEOUS

Model Number	G26900
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	10/05/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Non-healthcare professional.(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, during inflation the atb advance balloon catheter was inflated to just below/at burst rated pressure (approximately 15 atmospheres was reported) and the balloon ruptured circumferentially.This occurred during an angioplasty at the arterial anastomosis of an arteriovenous fistula.A circumferential tear occurred, not the expected lateral tear resulting in a foreign body within the fistula.The physician tried to snare the foreign body from the access site and was unsuccessful, but was able to pin the foreign body against the vessel wall to prevent migration.The physician obtained access from below and was able to remove the foreign body with the use of another manufacturer's 7fr sheath.At this time the patient is doing well, but this caused a delay in the procedure.Reportedly, optiray320 one-third strength was the contrast used.The fistula had minimal angulation and minimal calcification.A cook uniglide guide wire was in place during the retrieval attempt.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Investigation evaluation.A review of the dimensional verification, complaint history, device history record, documentation, drawing, instructions for use (ifu), quality control, and a visual inspection of the returned device was conducted during the investigation.The visual inspection of the returned device confirmed that the balloon had ruptured circumferentially with longitudinal tears present in the balloon material.The balloon material and catheter beneath the balloon had separated from itself.A small portion of the catheter was also damaged and came off during the investigation.Both marker bands were present.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 showed no nonconforming events which could contribute to this failure mode.It should be noted there were no other reported complaints for this lot number.Furthermore, a review of the manufactures instructions and quality control procedures was conducted, and no gaps were discovered.Moreover, an ifu is provided with the complaint device, which states ¿the intended use for the device does include obstructive lesions of native or synthetic arteriovenous dialysis fistulae.The instructions section states to use a 1:1 mixture of contrast medium and normal saline for the inflation medium.The ifu includes a warning to not exceed the rated burst pressure as this may cause the balloon to rupture.The strain relief of the device itself and the product labeling also indicates that the rated burst pressure is 15.¿ based on the information provided, the examination of the returned product, and the results of our investigation, a definitive root cause could not be established.We will continue our monitoring of similar complaints and have 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.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.
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: ATB ADVANCE BALLOON CATHETER
• Common Device Name: DQY CATHETER, PERCUTANEOUS
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 7988156
• Report Number: 1820334-2018-03165
• Device Sequence Number: 16490474
• Product Code: DQY
• UDI-Device Identifier: 00827002269002
• UDI-Public: (01)00827002269002(17)200426(10)8843079
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K033875
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/09/2019

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: 04/26/2020
• Device Model Number: G26900
• Device Catalogue Number: ATB5-35-80-7-4.0
• Device Lot Number: 8843079
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/17/2018
• Initial Date Received by Manufacturer: 10/05/2018
• Supplement Date Received by Manufacturer: 12/28/2018
• Initial Report FDA Received Date: 10/20/2018
• Supplement Report FDA Received Date: 01/10/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: PREVIOUSLY STATED.
• Outcome Attributed to Adverse Event: Required Intervention