MAUDE Adverse Event Report: COOK INC ADVANCE 14 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	03/13/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The product will not be returned for evaluation.The event is currently under investigation.
Event or Problem Description
It was reported that during an endovascular treatment (evt), using an advance 14 low profile balloon catheter, the device was advanced contralaterally from the femoral artery (fa).The patient's anatomy was said to be suitable for the procedure however, when the physician attempted to inflate the balloon at the target lesion, the balloon ruptured.It is unknown the direction in which the balloon ruptured.No adverse effect to the patient was 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 for the finished product shows no nonconforming events which could contribute to this failure mode.It should be noted there were no additional complaints of this failure mode associated with this lot number.Per the quality engineering risk assessment, no further action is required.We will continue to monitor for similar complaints.
Event or Problem Description
It was reported that during an endovascular treatment (evt), using an advance 14 low profile balloon catheter, the device was advanced contralaterally from the femoral artery (fa).The patient's anatomy was said to be suitable for the procedure however, when the physician attempted to inflate the balloon at the target lesion, the balloon ruptured.It is unknown the direction in which the balloon ruptured.No adverse effect to the patient was reported.The advance 14 lp low profile balloon catheter was replaced with another manufacturer's device to complete the procedure.

• Brand Name: ADVANCE 14 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: 6481039
• Report Number: 1820334-2017-00610
• Device Sequence Number: 13752588
• Product Code: DQY
• UDI-Device Identifier: 10827002503172
• UDI-Public: (01)10827002503172(17)171218(10)5527996
• Combination Product (Y/N): N
• PMA/510(K) Number: K090822
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/30/2017

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: PTAX4-14-170-2-12
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 03/13/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/11/2017
• Supplement Report FDA Received Date: 05/30/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1