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 Separation (1562)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/06/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device has been requested and not yet received.The event is currently under investigation.
Event or Problem Description
It was reported that during an unspecified procedure with an advance 35 lp low profile balloon catheter, the balloon ruptured (captured in medwatch with mfr number 1820334-2017-01818) and the catheter separated (captured in this medwatch with mfr number 1820334-2017-02248).No section of the device remained inside the patient's body.There were no reported adverse effects on the patient due to this occurrence.
Additional Manufacturer Narrative
Investigation - evaluation: a review of the complaint history, drawings, device history record, documentation, instructions for use (ifu), specifications, quality control, and visual inspection of the returned device was conducted during the investigation.One used advance 35lp low profile balloon catheter was returned for examination.The balloon catheter was returned separated.An unknown wire guide was returned inserted through the distal separated portion of the balloon catheter.Catheter is separated at 74.0cm from the proximal end.The distal separated section is 14.3cm in length.The balloon is separated.Distal separated section of balloon is accordioned.Proximal pied of catheter tubing is 71.2cm in length.The distal separated section of the catheter tubing is 13.6cm in length.Combined length = 84.8cm.Proximal section of the balloon is 26mm and the distal section = 30mm.The balloon separated radially.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 no nonconforming events that would contribute to this failure mode.There was one other reported complaint for this lot number and it was associated with this same event.The balloons are 100% inspected and verified for any defects prior to release.Per the physician, it was a "tight lesion" and "the vessel was highly calcified." calcifications can have unexpected sharp protrusions which can damage the balloon and contribute to rupture and/or tear.Based upon the information provided and the characteristics displayed, it is possible that the patient 's anatomy is related to the device failure.However, at this time a definitive root cause cannot 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: 6758107
• Report Number: 1820334-2017-02248
• Device Sequence Number: 16496962
• Product Code: DQY
• UDI-Device Identifier: 10827002523330
• UDI-Public: (01)10827002523330(17)191114(10)7441763
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K091527
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/08/2017

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: PTA5-35-80-4-8.0
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 07/19/2017
• Supplement Date Received by Manufacturer: 10/25/2017
• Initial Report FDA Received Date: 08/01/2017
• Supplement Report FDA Received Date: 11/08/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1