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

Model Number	N/A
Medical Device Problem Codes	Inflation Problem (1310); Material Rupture (1546)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/28/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The event is currently under investigation.A follow-up report will be submitted upon receipt of additional information and/or completion of the investigation.
Event or Problem Description
An international customer reported that during an endovascular aneurysm repair (evar) via femoral approach, an unspecified stent graft was placed in the patient.Then a non-cook stent was placed in the iliac artery to reinforce the leg of the stent graft.Post-dilation of the non-cook stent was conducted first with an advance 35 lp low profile balloon catheter, which was used without any problem.Then, the physician dilated the lesion further with a larger-diameter balloon.The advance 35 lp low profile balloon catheter was advanced to the target site and inflation was attempted.However, the balloon would not inflate well and ruptured at nominal pressure.It was replaced with another unspecified balloon and the procedure was completed successfully.There were no adverse effects to the patient.Further information has been requested.
Additional Manufacturer Narrative
Investigation ¿ evaluation: a review of the complaint history, device history record, documentation, drawing, instructions for use (ifu), specifications, quality control, was conducted during the investigation.The complaint device was not returned; therefore, no physical examination could be performed.However, a document based investigation was performed.There is no evidence to suggest the finished product was not made to specifications.Review of the device history record of the finished product shows one nonconforming event that could contribute to this failure mode.There were no other reported complaints for this lot number.Numerous design verification and validation activities have been performed to ensure that this device meets design requirements.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 required.Appropriate personnel have been notified and 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: 6908296
• Report Number: 1820334-2017-03468
• Device Sequence Number: 10937580
• Product Code: DQY
• UDI-Device Identifier: 10827002523668
• UDI-Public: (01)10827002523668(17)180116(10)5584715
• 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,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/02/2017

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: PTA5-35-80-9-4.0
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/29/2017
• Supplement Date Received by Manufacturer: 11/01/2017
• Initial Report FDA Received Date: 10/02/2017
• Supplement Report FDA Received Date: 11/16/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1