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	09/19/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Common name and product code = pno, catheter, percutaneous, cutting/scoring.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
As reported, during an unknown procedure of the common femoral artery of a patient of unknown demographics, an advance enforcer 35 focal force pta balloon catheter ruptured on initial inflation to "normal" pressure.The patient reportedly had heavy vessel calcification, as well as angulation and tortuosity in the common femoral artery.The balloon was not inflated inside of a stent prior to rupturing.The ruptured balloon was removed and replaced with an unknown scoring balloon to complete the procedure.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.Additional information regarding event details, patient anatomy and outcome has been requested, but is not available at this time.
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: reviews of the complaint history, device history record, documentation, drawing, instructions for use (ifu), manufacturer¿s instructions, and quality control procedures of the device were conducted during the investigation.The complaint device was not returned; therefore, no physical examinations could 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 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.Furthermore, reviews of the manufacturer¿s instructions, drawings, and quality control procedures were conducted, and no gaps were discovered.Also, an ifu is provided with this device, which warns not exceed the rated burst pressure, use a power injector, or inject contrast through the wire guide lumen.If balloon pressure is lost and/or balloon rupture occurs, the balloon is to be deflated and removed with the sheath as a unit.Based on the findings of the investigation, there is no evidence to suggest that the device was not manufactured to specifications, nor have there been complaints with similar occurrences in the reported lot.There is no evidence to suggest that the clinician misused the device.The information provided at this time does not provide a clear indication for the cause of shaft separation and is therefore deemed as inconclusive.We will continue our monitoring of similar complaints and have notified the appropriate personnel of this event.Per the quality engineering risk assessment no further action is required.This report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or 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: 9280445
• Report Number: 1820334-2019-02785
• Device Sequence Number: 3389398
• Product Code: PNO
• UDI-Device Identifier: 10827002352572
• UDI-Public: (01)10827002352572(17)220719(10)9891000
• Combination Product (Y/N): N
• Initial Reporter State: DE
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/02/2020

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: 07/19/2022
• Device Model Number: G35257
• Device Catalogue Number: ASB5-35-135-6-4
• Device Lot Number: 9891000
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/21/2019
• Supplement Date Received by Manufacturer: 12/31/2019
• Initial Report FDA Received Date: 11/05/2019
• Supplement Report FDA Received Date: 01/02/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1