MAUDE Adverse Event Report: COOK INC ADVANCE 35 LP LOW PROFILE BALLOON CATHETER; LIT CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number	N/A
Medical Device Problem Codes	Hole In Material (1293); Defective Device (2588)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/26/2017
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
An advance 35 lp low profile balloon catheter was used for a superficial femoral artery (sfa) procedure.It was reported that the balloon would not stay inflated; once the balloon was removed, a pinhole leak was discovered.There was vessel calcification noted but no angulation.Patient outcome was not reported however, there was no medical/surgical intervention performed.
Additional Manufacturer Narrative
Investigation - evaluation: a review of the complaint history, drawings, device history record, documentation, instructions for use (ifu), quality control data, and visual inspection of the returned device was conducted during the investigation.One used advance 35lp low profile balloon catheter was returned for evaluation.The balloon was inflated and a pinhole was observed at the proximal bond.A document-based investigation was performed.Review of the device history record of the finished product shows three nonconforming events that may contribute to this failure mode.There were no other reported complaints for this lot number.All balloons are 100% inspected prior to release.It was stated that there was vessel calcification.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, 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: LIT CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 6760980
• Report Number: 1820334-2017-02251
• Device Sequence Number: 1947835
• Product Code: LIT
• UDI-Device Identifier: 10827002355320
• UDI-Public: (01)10827002355320(17)200309(10)7738030
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K132020
• 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): 11/09/2017

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: PTA5-35-135-5-20.0
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 07/27/2017
• Supplement Date Received by Manufacturer: 10/27/2017
• Initial Report FDA Received Date: 08/02/2017
• Supplement Report FDA Received Date: 11/09/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1