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

Catalog Number	PTA5-35-135-7-8.0
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/16/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event is currently under investigation.
Event or Problem Description
It was reported that an advance 35 low profile balloon catheter was being used for pre-dilation of an in-stent occlusion of an iliac artery.The balloon ruptured.It is unknown which direction the balloon ruptured.An attempt was made to use a second advance 35 lp low profile balloon catheter, see mfr report 1820334-2017-00705.The second catheter ruptured as well.Another manufacturer's device was then used to perform pre-dilation.After another manufacturer's stent placement during post-dilation the vessel ruptured.Another manufacturer's stent graft was then placed to complete the procedure.There have been no adverse effects to the patient reported.
Additional Manufacturer Narrative
Investigation - evaluation: a review of the complaint history, drawings, device history record, documentation, instructions for use (ifu), specifications, and quality control of the device was conducted during the investigation.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.It should be noted there were no other reported complaints for this lot number.Without visual, dimensional, and/or functional testing of the product any manufacturing related issues related to the rupture of the balloon were unable to be determined.Additionally, factors that may have contributed to the reported failure include the attempted placement of the stent into the patient's already occluded iliac artery and history of cta of the sfa.With the information provided and the results of the manufacturer investigation it is likely that the reported event may be related to intraprocedural complications related to the patient's preexisting condition; however, this cannot be conclusively determined.We will continue to monitor for similar complaints.Per the quality engineering risk assessment no further action is required.

• 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: 6486751
• Report Number: 1820334-2017-00704
• Device Sequence Number: 1289681
• Product Code: DQY
• UDI-Device Identifier: 10827002522746
• UDI-Public: (01)10827002522746(17)180120(10)5590704
• 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: user facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/10/2017

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 Catalogue Number: PTA5-35-135-7-8.0
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 03/16/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/12/2017
• Supplement Report FDA Received Date: 05/10/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1