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	07/06/2017
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 or completion of the investigation.
Event or Problem Description
It was reported that during an unspecified procedure with an advance 35 lp low profile balloon catheter, the balloon popped.Another balloon was opened to complete the procedure.No unintended 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, device history record, documentation, drawing, instructions for use, specifications, quality control data, and visual inspection of the returned device were conducted during the investigation.One used advance 35lp low profile 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 74.0com from the proximal end.The distal separated section is 14.3cm in length.The balloon separated radially.The distal separated section of the balloon was accordioned.The balloon separated radially.Review of the device history record of the finished product shows no nonconforming events that would contribute to this failure mode.There were no other reported complaints for this lot number.Per the physician, it was a "tight lesion" and "the vessel was highly calcified." there is no information regarding any difficulties encountered during the procedure.Therefore, based upon the information provided and the characteristics displayed, the most likely root cause may be related to user handling or patient anatomy.Per the quality engineering risk assessment, no further action is required.We will notify the appropriate personnel and continue to monitor for similar complaints.
Event or Problem Description
It was reported that during an unspecified procedure with an advance 35 lp low profile balloon catheter, the balloon popped.This reportedly occurred in association with a tight lesion on an unknown part of the body.The vessel was reportedly highly calcified.Another balloon was opened to complete the procedure.No unintended section of the device remained inside the patient's body.There were no reported adverse effects on the patient due to this occurrence.

• 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: 6733658
• Report Number: 1820334-2017-01818
• Device Sequence Number: 724960
• 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): 08/10/2017

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 Model Number: N/A
• Device Catalogue Number: PTA5-35-80-4-8.0
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 07/06/2017
• Supplement Date Received by Manufacturer: 07/26/2017
• Initial Report FDA Received Date: 07/21/2017
• Supplement Report FDA Received Date: 08/10/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other