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

Model Number	N/A
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/22/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The event is currently under investigation.
Event or Problem Description
It was reported that the low profile balloon catheter section that connected the part of balloon and catheter was rough and failed to go through the vessel sheath during the procedure.The balloon was withdrawn from the patient and the operation was cancelled as another device was not available to complete the procedure.It is unknown at the time of this report if another procedure was performed at a later date.A section of the device did not remain inside the patient's body.The patient did not require any additional procedures nor experience any adverse effects due to this occurrence.
Additional Manufacturer Narrative
(b)(4).Product has been received and the investigation is ongoing.A follow up report will be sent upon completion of the investigation.
Event or Problem Description
It was reported that the low profile balloon catheter section that connected the part of balloon and catheter was rough and failed to go through the vessel sheath during the procedure.The balloon was withdrawn from the patient and the operation was cancelled as another device was not available to complete the procedure.It is unknown at the time of this report if another procedure was performed at a later date.A section of the device did not remain inside the patient's body.The patient did not require any additional procedures nor experience any adverse effects due to this occurrence.
Additional Manufacturer Narrative
Investigation - the device was returned for evaluation.Visual inspection notes catheter shaft separation.Proximal segment of device measures 70.7 cm in length and the distal segment measures 8 cm in length.Kinks are noted along the entire length of the shaft.There is no evidence that the device was not manufactured to specification.Based on the available information root cause cannot be determined.A review of the complaint history, device history record, ifu, quality control and visual inspection of the returned device was conducted.No events related to the reported issue were found during a review of related manufacturing or quality records.Review of the associated device history record did not identify non-conformances that may be related to this reported incident.

• 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: 5852947
• Report Number: 1820334-2016-00780
• Device Sequence Number: 1356919
• Product Code: DQY
• UDI-Device Identifier: 10827002523729
• UDI-Public: (01)10827002523729(17)190531(10)NS7010600
• Combination Product (Y/N): N
• Initial Reporter Country: CN
• PMA/510(K) Number: K091527
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/25/2016

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: PTA5-35-80-10-3.0
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 07/25/2016
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 08/08/2016
• Supplement Report FDA Received Date: 11/07/2016; 02/06/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1