MAUDE Adverse Event Report: CORDIS DE MEXICO POWERFLEXPRO 12MM2CM 80; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number	4401202S
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/28/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was not returned for analysis.Additional information is pending and will be submitted within 30 days upon receipt.
Event or Problem Description
It was reported that a power flex pro balloon rupture at its normal pressure.It was unknown how the procedure completed however the procedure was finished successfully.There was no reported patient injury.The target lesion was unknown.The patient¿s vessel level of tortuousness and calcification was unknown.The rate of stenosis was unknown.The product was clinically used and will not be returned for analysis.
Additional Manufacturer Narrative
A powerflex pro balloon catheter (bc) ruptured at its normal pressure.It was unknown how the procedure completed however the procedure was finished successfully.There was no reported patient injury.The target lesion was unknown.The patient¿s vessel level of tortuousness and calcification was unknown.The rate of stenosis was unknown.The device was not returned for analysis.A device history record (dhr) review of lot 17458059 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿balloon burst-at/below rbp (peripheral)¿ could not be confirmed as the device was not returned for analysis.The exact cause could not be determined.Vessel characteristics were not provided.According to the instructions for use (ifu), ¿the rated burst pressure is based on the results of in vitro testing.At least 99.9% of the balloons (with a 95% confidence), will not burst at or below their rated burst pressure.Use of a pressure monitoring device is recommended to prevent over pressurization.¿ neither the dhr nor the information available suggests a design or manufacturing related cause for the reported event; therefore, no corrective/preventive action will be taken.

• Brand Name: POWERFLEXPRO 12MM2CM 80
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): CORDIS DE MEXICO; circuito int nte 1820; juarez 32575 ; MX 32575
• MDR Report Key: 6123438
• Report Number: 9616099-2016-00753
• Device Sequence Number: 16181459
• Product Code: LIT
• UDI-Device Identifier: 20705032059777
• UDI-Public: 20705032059777
• Combination Product (Y/N): N
• PMA/510(K) Number: K112797
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/17/2017

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 Expiration Date: 03/31/2019
• Device Model Number: 4401202S
• Device Catalogue Number: 4401202S
• Device Lot Number: 17458059
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 10/29/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 10/29/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/22/2016
• Supplement Report FDA Received Date: 01/17/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1