MAUDE Adverse Event Report: COOK INC ADVANCE 18 LP LOW PROFILE BALLOON CATHETER; LIT CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number	N/A
Medical Device Problem Codes	Crack (1135); Material Separation (1562)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/03/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Pma/510(k) #: k130293.The event is currently under investigation.
Event or Problem Description
It was reported that during a lower leg angiogram procedure using an advance 18 low profile balloon catheter, the hub of the catheter separated.No unintended section of the device remained inside the patient's body.Another device was used to complete the procedure.There were no adverse effects on the patient reported due to this occurrence.
Additional Manufacturer Narrative
(b)(4).Investigation - evaluation: a review of complaint history, device history record, documentation, drawing, specifications, quality control, functional testing and visual inspection of the returned device was conducted during the investigation.One used advance 18lp low profile balloon catheter was returned for examination.Three cracks were noted on the balloon port of the hub.An attempt was made to inflate the balloon.The balloon would not inflate due to the cracks in the balloon port.There is no evidence to suggest the product was not made to specifications.Review of device history record shows no nonconforming events which could contribute to this failure mode.It should be noted there were no other reported complaints for this lot number.Based on the provided information and device evaluation, a definitive root cause cannot be conclusively be determined.Per the quality engineering risk assessment no further action is required.Monitoring for similar complaints will continue.

• Brand Name: ADVANCE 18 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: 6602576
• Report Number: 1820334-2017-01031
• Device Sequence Number: 324934
• Product Code: LIT
• UDI-Device Identifier: 10827002343365
• UDI-Public: (01)10827002343365(17)200222(10)7697844
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/18/2017

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: PTA4-18-150-6-8
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 05/03/2016
• Supplement Date Received by Manufacturer: 07/10/2017
• Initial Report FDA Received Date: 05/31/2017
• Supplement Report FDA Received Date: 07/18/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1