MAUDE Adverse Event Report: COOK INC ADVANCE ENFORCER 35 FOCAL FORCE PTA BALLOON CATHETER

Model Number	G35257
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/19/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Common name & product code: catheter, percutaneous, cutting/scoring; pno.Pma/510(k) number: k141322.This report includes information known at this time.A follow-up report will be submitted should additional relevant information become available.
Event or Problem Description
It was reported, an advance enforcer 35 focal force pta balloon catheter ruptured at 6-8atm (atmospheres) during an atherectomy procedure.No part separated.A (b)(6) male was undergoing an atherectomy of the highly calcified left common femoral artery.The complaint device was inflated and the atherectomy performed.A second inflation was attempted after the atherectomy and the balloon ruptured.An inflation device was used along with a 50/50 ratio of visiopaque contrast to saline.There was no vessel tortuosity or angulation.It is not known if the balloon ruptured circumferentially or longitudinally.Neither a re-wrapping tool nor a sheath were used to remove the balloon.The procedure had been completed prior to the rupture.A section of the device did not remain inside the patient¿s body.The patient did not require any additional procedures due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.According to the complainant, the complaint device was discarded at the facility.
Event or Problem Description
No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.
Additional Manufacturer Narrative
Investigation - evaluation a review of the complaint history, drawings, device history record, instructions for use (ifu), and quality control was conducted during the investigation.The complaint device was not returned for investigation; therefore, a physical evaluation could not be performed.However, 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.The balloon catheter sub-assembly was also reviewed.No nonconformances were noted.The product labeling and instructions for use were reviewed.The documentation provides an accurate depiction of how to use the device along with illustrations describing the appropriate inflation pressure.There is no indication that the clinician inflated the balloons past the rated burst pressure or acted in a way that caused the balloons to burst.Based on the information provided, the examination of the returned product, and the results of our investigation, it has been concluded the cause of this event could not be established; however, appropriate measures have been initiated to address this failure mode.We will continue to monitor for similar complaints.Per the quality engineering risk assessment no further action is required.This report is required by the fda under 21 cfr part 803 and is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement contained herein is intended to be an admission that any cook device is defective or malfunctioned, that a death or serious injury occurred, nor that any cook device caused, contributed to, or is likely to cause or contribute to a death or serious injury if a malfunction occurred.

• Brand Name: ADVANCE ENFORCER 35 FOCAL FORCE PTA BALLOON CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 8363488
• Report Number: 1820334-2019-00429
• Device Sequence Number: 16567918
• Product Code: PNO
• UDI-Device Identifier: 10827002352572
• UDI-Public: (01)10827002352572(17)211117(10)9320429
• 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,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/31/2019

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 Expiration Date: 11/17/2021
• Device Model Number: G35257
• Device Catalogue Number: ASB5-35-135-6-4
• Device Lot Number: 9320429
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/19/2019
• Supplement Date Received by Manufacturer: 05/28/2019
• Initial Report FDA Received Date: 02/22/2019
• Supplement Report FDA Received Date: 05/31/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 65 YR
• Patient Weight: 81