MAUDE Adverse Event Report: CORDIS DE MEXICO POWERFLEXPRO 8MM4CM 135; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number	4400804X
Medical Device Problem Codes	Burst Container or Vessel (1074); Detachment Of Device Component (1104)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/27/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The product was not returned for analysis.Device history record (dhr) review was conducted and the product met quality requirements for product acceptance.Additional information is pending and will be submitted within 30 days upon receipt.
Event or Problem Description
Additional information was received and it was reported that the powerflex pro 8mm4cm 135 balloon burst and a piece of the balloon was not retrieved.
Additional Manufacturer Narrative
It was reported that the powerflex pro 8 mm 4 cm 135 balloon burst and a piece of the balloon was not retrieved.The device was not returned for analysis.A device history record (dhr) review of lot 17467398 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿balloon burst ¿ in patient¿ and ¿balloon separated - in-patient¿ could not be confirmed as the device was not returned for analysis.The exact cause could not be determined.Based on the limited information available for review, it is not possible to determine what factors may have contributed to the issue reported.However, lesion and procedural factors are likely.According to the instructions for use (ifu), ¿according to the instructions for use ¿if resistance is met during manipulation, determine the cause of the resistance before proceeding.Balloon pressure should not exceed the rated burst pressure.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.Use only the recommended balloon inflation medium.Never use air or any gaseous medium to inflate the balloon.Prior to angioplasty, the catheter should be examined to verify functionality and ensure that its size and shape are suitable for the specific procedure for which it is to be used.¿ 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 8MM4CM 135
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): CORDIS DE MEXICO; circuito int nte 1820; juarez 32575 ; MX 32575
• MDR Report Key: 6147314
• Report Number: 9616099-2016-00781
• Device Sequence Number: 407762
• Product Code: LIT
• UDI-Device Identifier: 20705032059821
• UDI-Public: 20705032059821
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K112797
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2019
• Device Model Number: 4400804X
• Device Catalogue Number: 4400804X
• Device Lot Number: 17467398
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 11/10/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 11/10/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/06/2016
• Supplement Report FDA Received Date: 01/19/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1