MAUDE Adverse Event Report: CORDIS CORPORATION POWERFLEXPRO 8MM2CM 135; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number	4400802X
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/12/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).During use, it was reported that the 8x20mm 135cm powerflex pro balloon catheter (bc) was delivered to the lesion and was attempted to be inflated.However, the balloon ruptured at its nominal pressure during its initial inflation.Therefore the powerflex balloon was replaced with a new balloon catheter and the procedure was completed.There was no patient injury.The lesion was the superficial femoral artery which was severely calcified.The device was not returned for analysis.A device history record (dhr) review of lot 82148552 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¿ could not be confirmed as the device was not returned for analysis.The exact cause of the burst could not be determined.Based on the limited information available for review, lesion characteristics (severely calcified) and procedural/handling factors may have contributed to the reported event since calcified/resistant lesions can cause damage to a balloon.According to the instructions for use, which is not intended as a mitigation, ¿the rated burst pressure is based on the result of in vitro testing.At least 99.9% of the balloons (with a 95% confidence level) will not burst at or below their rated burst pressure.Use of a pressure monitoring device is recommended to prevent over pressurization.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 review nor the information available suggests a design or manufacturing related cause for the reported event.Therefore, no corrective/preventive action will be taken at this time.
Event or Problem Description
During use, it was reported that the powerflex pro balloon catheter was delivered to the lesion and was attempted to be inflated.However, the balloon ruptured at its nominal pressure during its initial inflation.There was no patient injury.Therefore the powerflex balloon was replaced with a new balloon catheter and the procedure was completed.The lesion was the superficial femoral artery which was severely calcified.No other information was provided.

• Brand Name: POWERFLEXPRO 8MM2CM 135
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60th avenue; miami lakes 33014
• MDR Report Key: 8045763
• Report Number: 9616099-2018-02501
• Device Sequence Number: 13824224
• Product Code: LIT
• UDI-Device Identifier: 20705032059784
• UDI-Public: 20705032059784
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K112797
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/07/2018

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 Expiration Date: 10/31/2020
• Device Model Number: 4400802X
• Device Catalogue Number: 4400802X
• Device Lot Number: 82148552
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/12/2018
• Initial Report FDA Received Date: 11/07/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1