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

Catalog Number	PTA4-18-150-6-20
Medical Device Problem Codes	Material Rupture (1546); Material Separation (1562)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/12/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Pma/510(k) number = k130293.(b)(4).The event is currently under investigation.A supplemental report will be provided upon conclusion.
Event or Problem Description
It was reported that during a percutaneous transluminal angioplasty (pta) for a superficial femoral artery (sfa) lesion, the advance 18 lp low profile balloon catheter ruptured at an inflation pressure of 10 atmosphere (atm).The balloon catheter was removed, and another advance 18 lp low profile balloon catheter was used to successfully complete the procedure.The patient's vessels were noted to be calcified.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.
Additional Manufacturer Narrative
During inspection following receipt of the complaint device on 21dec2017, the advance 18 lp low profile balloon catheter was observed to be separated in three sections.(b)(4).Investigation - evaluation: a preliminary review of the complaint history, drawings, device history record, documentation, instructions for use (ifu), specifications, quality control, and visual inspection of the returned device was conducted during the investigation.One used advance 18 lp low profile balloon catheter was returned for evaluation.The catheter was returned separated in three sections.A portion of the balloon was not returned.The balloon separated at the proximal bond.No marker bands are present.Separation sites are torn.Hub and strain relief show no non-conformances.Crows feet could not visualized due to damage to the balloon.The balloon was observed to have burst radially.A document-based investigation was performed.There is no evidence to suggest the finished product was not made to specifications.Numerous design verification and validation activities have been performed to ensure that this device meets design requirements.Review of the device history record of the finished product shows four nonconforming events that could contribute to this failure mode; the affected parts were scrapped.A complaint history search revealed that there were no other reported complaints for this lot number.Per the ifu, "the balloon is manufactured from an extra-thinwall, high-strength, minimally-compliant material.Particular care should be taken in handling the balloon to prevent damage.If resistance is met while advancing the balloon dilatation catheter, determine the cause and proceed with caution.Inflate balloon to desired pressure." this report includes information known at this time. a follow-up report will be submitted should additional relevant information become available.
Additional Manufacturer Narrative
Investigation - evaluation: a review of the complaint history, drawings, device history record, documentation, instructions for use (ifu), specifications, quality control, and visual inspection of the returned device was conducted during the investigation.Based on the information provided, examination of the returned product, and the results of our investigation, the root cause for the rupture can be attributed to patient anatomy due to heavy arterial calcification.Appropriate measures have been initiated to address this failure mode.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 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: 7114825
• Report Number: 1820334-2017-04490
• Device Sequence Number: 1895714
• Product Code: LIT
• UDI-Device Identifier: 10827002309644
• UDI-Public: (01)10827002309644(17)200919(10)8227312
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/09/2018

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: PTA4-18-150-6-20
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 12/13/2017
• Supplement Date Received by Manufacturer: 12/21/2017; 02/05/2018
• Initial Report FDA Received Date: 12/13/2017
• Supplement Report FDA Received Date: 01/18/2018; 02/09/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1