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	07/29/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).(b)(4).The event is currently under investigation.
Event or Problem Description
It was reported that during a post-dilation procedure, with approach from the left common femoral artery (cfa), a catheter balloon was inflated for post dilation after stent deployment, to treat chronic total occlusion (cto) in the external iliac artery (eia).The balloon reportedly ruptured at nominal pressure.Another balloon with the same specifications was used instead, and the procedure was completed successfully.There have been no adverse effects to the patient reported.
Additional Manufacturer Narrative
(b)(4).Investigation - evaluation a review of the complaint history, device history record, documentation, instructions for use (ifu), specifications and quality was conducted during the investigation.The device is shipped with an instruction for use (ifu) that describes the intended use, specific items are addressed such as: 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.Use only the recommended balloon inflation medium.Never use air or any gaseous medium to inflate the balloon.If balloon pressure is lost and/or balloon rupture occurs, deflate balloon and remove balloon and sheath as a unit.Without benefit of visual, dimensional, or functional testing of the device, the investigation cannot determine with certainty what led to this failure mode.However, there is no documentation of the technique used to inflate or retrieve the balloon that can confirm user error, statements speaking to the exact rated burst pressure (rbp) during the time of rupture or evidence confirming that the balloon burst circumferentially or longitudinally which can increase risk.Also, no severe calcification was observed which can contribute to the device deficiency.The complaint device was not returned therefore, no physical examinations could be performed; however, a document based investigation evaluation was performed.There is no evidence to suggest the product was not made to specifications.Review of device history record shows no nonconforming events which could contribute to this failure mode.Based on the information provided, no product returned and the results of our investigation, a definitive root cause could not be determined.The appropriate internal personnel have been notified and we will continue to monitor for similar complaints.Per the quality engineering risk assessment (qera) no further action is required.
Event or Problem Description
It was reported that during a post-dilation procedure, with approach from the left common femoral artery (cfa), a catheter balloon was inflated for post dilation after stent deployment, to treat chronic total occlusion (cto) in the external iliac artery (eia).The balloon reportedly ruptured at nominal pressure.Another balloon with the same specifications was used instead, and the procedure was completed successfully.There have been no adverse effects to the patient reported.

• 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: 5888293
• Report Number: 1820334-2016-00847
• Device Sequence Number: 16316759
• Product Code: DQY
• UDI-Device Identifier: 10827002523583
• UDI-Public: (01)10827002523583(17)180227(10)5682986
• 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: distributor,foreign
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/01/2016

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 Model Number: N/A
• Device Catalogue Number: PTA5-35-80-8-2.0
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 08/01/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/19/2016
• Supplement Report FDA Received Date: 10/14/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1