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

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	08/11/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Pma/510(k)# - k130293.The event is currently under investigation.A supplemental report will be provided upon conclusion.
Event or Problem Description
It was reported, during an aortic iliac intervention involving a (b)(6) year old male patient, the advance 18 lp low profile pta balloon dilatation catheter was removed and a piece snapped off.No pieces of the device remained inside the patient.No injuries or additional medical intervention were reported.
Additional Manufacturer Narrative
Investigation - evaluation: a review of the complaint history, dimensional verification, device history record, documentation, instructions for use (ifu), manufacturing instructions, trends, quality control, and visual inspection of the returned device was conducted during the investigation.One used advance 18 lp low profile pta balloon dilatation catheter was returned for investigation.No damage was noted to the catheter or hub; however, the distal end of the balloon is missing.The proximal marker band is present.The distal marker band is not present.The separated balloon edge is jagged and at a 65 degree angle.Both the measurements for the catheter length and balloon length were out of tolerance.A document-based investigation was performed.Review of the device history record of the finished product shows no nonconforming events that could contribute to this failure mode.A complaint history search revealed that there were no other reported complaints for this lot number.Without additional information, we are unable to determine if the failure of the device was attributed to device handling, user technique, and/or patient anatomy.Based on the information provided, examination of the returned product, and the results of our investigation, a definite root cause could not be determined.If additional information is provided, this investigation will be reopened and a supplemental report will be provided.Per the quality engineering risk assessment, no further action is required.Monitoring will continue to be performed for similar complaints.

• Brand Name: ADVANCE 18 LP LOW PROFILE PTA BALLOON DILATATION CATHETER
• Common Device Name: LIT CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 6792889
• Report Number: 1820334-2017-02499
• Device Sequence Number: 16529285
• Product Code: LIT
• UDI-Device Identifier: 10827002308524
• UDI-Public: (01)10827002308524(17)200321(10)7766202
• 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: Radiologic Technologist
• Type of Report: Initial,Followup
• Report Date (Section B): 11/15/2017

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: PTAX4-18-170-6-4
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 08/14/2017
• Supplement Date Received by Manufacturer: 10/25/2017
• Initial Report FDA Received Date: 08/14/2017
• Supplement Report FDA Received Date: 11/15/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 77 YR