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 Codes	Break (1069); Material Separation (1562)
Health Effect - Clinical Codes	Device Embedded In Tissue or Plaque (3165); No Code Available (3191)
Date of Event	10/06/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional information: pma/510(k) #: k130293.(b)(4).The event is currently under investigation.A supplemental report will be provided upon conclusion.
Event or Problem Description
An advance 18 lp low profile pta balloon dilatation catheter was used in a pta/stent procedure in the right superficial femoral artery with severe calcification.It was reported that the balloon was being removed over the wire when the shaft broke at the "rx exit port".The broken portion of the balloon was removed using a snare.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.
Additional Manufacturer Narrative
Investigation ¿ evaluation: a review of the dimensional verification, complaint history, device history record, instructions for use (ifu), manufacturing instructions, quality control, and a visual inspection and functional evaluation of the returned device were conducted during the investigation.The visual inspection of the returned device confirmed that the catheter was separated into two sections.The catheter appeared elongated.The proximal section was measured to be 122.8 cm in length, and the distal section was measured to be 57.5 cm in length.The total length was measured to be 180.3 cm, which is outside the upper limit specification for length.Additionally, a document based investigation evaluation was performed.There is no evidence to suggest the product was not made to specifications.A review of the device history record showed 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 information provided, the examination of the returned product, and the results of our investigation, a definitive root cause could not be determined.It is likely, however, that patient condition and user technique are related to the event.We will continue to monitor for similar complaints.Per the quality engineering risk assessment no further action is required.
Additional Manufacturer Narrative
Additional information received on 14nov2017 (user facility (uf) voluntary medwatch (b)(4)): per the uf medwatch, "balloon broke off from the catheter.Doctor able to remove balloon with snare.Balloon and catheter removed without difficulty or injury to patient.Balloon broke in half when physician attempted to remove it.Difficulty snaring the broken part from the patient but managed to retrieve and patient suffered no harm." (b)(4).The inflation pressure utilized during the event was reported to be at or below the rated burst pressure (rbp).Angulation was present.The sheath utilized during the procedure was a six (6) fr ansel; a wire guide was in place during attempted removal of the balloon catheter.The balloon was allowed to return to ambient pressure on negative pressure.The initial reporter stated that the balloon catheter was likely not rotated clockwise upon withdrawal.This report includes information known at this time. a follow-up report will be submitted should additional relevant information become available.(b)(4).

• 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: 6953574
• Report Number: 1820334-2017-03564
• Device Sequence Number: 891862
• Product Code: LIT
• UDI-Device Identifier: 10827002308449
• UDI-Public: (01)10827002308449(17)190705(10)7093411
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• 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,Followup
• Report Date (Section B): 04/02/2018

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?: No
• Operator of Device: No Information
• Device Model Number: N/A
• Device Catalogue Number: PTAX4-18-170-5-6
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 10/06/2017
• Supplement Date Received by Manufacturer: 11/14/2017; 03/09/2018
• Initial Report FDA Received Date: 10/16/2017
• Supplement Report FDA Received Date: 02/16/2018; 04/02/2018
• 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: Required Intervention
• Patient Age: 80 YR