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	02/07/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The reported device is not available for evaluation at this time; the event is currently under investigation.
Event or Problem Description
It was reported, during an unspecified procedure, an advance 35 lp low profile balloon catheter was used to treat severe calcified lesion of the external iliac artery, by way of the brachial artery, however the balloon ruptured.Another advance 35 lp was used instead to complete the procedure.There have been no adverse effects to the patient reported.The device will not be returned.
Additional Manufacturer Narrative
A review of the complaint history, drawings, device history record, manufacturing instructions, and quality control was conducted during the investigation.The complaint device was not returned, therefore no physical examinations could be performed; however, a document-based investigation was performed.There is no evidence to suggest the product was not made to specifications.Review of the device history record shows no nonconforming events that would contribute to this failure mode.There were no other reported complaints for this lot number.The device is shipped with instructions for use (ifu) that provide precautions to take while inflating to avoid rupturing the balloon.Based on the information provided, no product returned, and the results of our investigation; a definitive root cause could not be determined.Per the quality engineering risk assessment, no further action is warranted.Monitoring will continue to be performed 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: 6393015
• Report Number: 1820334-2017-00320
• Device Sequence Number: 442395
• Product Code: DQY
• UDI-Device Identifier: 10827002522654
• UDI-Public: (01)10827002522654(17)180121(10)5594534
• 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: foreign,user facility
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/27/2017

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 Model Number: N/A
• Device Catalogue Number: PTA5-35-135-6-4.0
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 02/07/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/09/2017
• Supplement Report FDA Received Date: 06/27/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1