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

Model Number	N/A
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/23/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The event is currently under investigation.
Event or Problem Description
It was reported that during a dialysis procedure using an advance 35 low profile balloon catheter, the balloon ruptured upon inflation.The balloon was past 12 atm (rate of burst).The direction of the balloon rupture was unknown.The balloon was very near a stent edge; through a stent.The lesion was in the forearm with no angulation or vessel calcification noted.The type of contrast that was used was a mix of contrast and saline, vispaque 50/50.The procedure was completed using the balloon of another (unspecified) manufacturer.The patient did not require any additional interventions or procedures as a result of this event.Additionally, there were no adverse effects to the patient reported.
Additional Manufacturer Narrative
Evaluation: a review was of the following: complaint history, device record, document, drawing, the instructions for use (ifu) and a visual inspection of the returned device.According to device history records, based on the lot number provided, there is no evidence to suggest that this device was not manufactured according to specifications.Per instructions for use: "the balloon is manufactured from an extra-thinwall, high-strength, minimally-compliant material.Particular care should be taken in handling the balloon to prevent damage.It will inflate to the indicated size parameters when utilizing proper pressure recommendations.Adhere to balloon inflation pressure parameters indicated in the compliance card insert.Refer to label for further information.Use of a pressure gauge is recommended to monitor inflation pressures." warnings: "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 pressures.Do not use power injector for balloon inflation of contrast medium through catheter lumen marked "distal." rupture may occur." instructions for use: "upon removal from package, inspect the catheter to ensure no damage has occurred during shipping." balloon introduction and inflation: "inflate balloon to desired pressure adhere to recommended balloon inflation pressures."how supplied: "store in a dark, dry cool place.Avoid extended exposure to light.Upon removal from package, inspect the product to ensure no damage has occurred." a complaint history search revealed this complaint to be the only reported complaint associated to the complaint lot number.The physical inspection of the returned device revealed the device did not rupture but had had two pinhole leaks.The customer states there was a stent edge and a lesion.It is feasible to suggest the balloon may have been damaged by the stent or patient anatomy upon insertion.It is feasible the balloon may have been damaged during handling during the procedure.Based upon the information provided and the characteristics displayed, it is plausible to suggest that this incident was technique related or human anatomy related.We will continue to monitor for similar complaints.

• 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: 6511090
• Report Number: 1820334-2017-00797
• Device Sequence Number: 10785968
• Product Code: DQY
• UDI-Device Identifier: 10827002523521
• UDI-Public: (01)10827002523521(17)200116(10)7593837
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/25/2017

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 Model Number: N/A
• Device Catalogue Number: PTA5-35-80-7-4.0
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 03/23/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/21/2017
• Supplement Report FDA Received Date: 05/25/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1