MAUDE Adverse Event Report: CORDIS CORPORATION POWERFLEXPRO 4MM4CM 135; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number	4400404X
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/27/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information is pending and will be submitted within 30 days upon receipt.
Event or Problem Description
As reported, a 4mm x 4cm x 135cm powerflex pro percutaneous transluminal angioplasty (pta) balloon catheter was used; but it ruptured at 4 atmospheres (atm).Therefore, it was replaced with another unknown balloon catheter and the procedure was completed.There was no reported patient injury.The device will not be returned for evaluation due to patient's infectious disease.
Additional Manufacturer Narrative
A powerflex pro 4mm x 4cm x 135cm percutaneous transluminal angioplasty (pta) balloon catheter was used; but it ruptured at 4 atmospheres (atm).Therefore, it was replaced with another unknown balloon catheter and the procedure was completed.There was no reported patient injury.The device was not returned for analysis.A product history record (phr) review of lot 82148335 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.Without the return of the device for analysis and based on the information provided, the reported ¿balloon~ burst - at/below rbp¿ could not be confirmed and the exact root cause could not be determined.It is difficult to draw a clinical conclusion between the device and the events based on the information available.However, it is probable that handling and procedural factors such as vessel characteristics (although unknown) may have contributed to the reported event as the presence of calcification is known to cause damage to balloons.According to the safety information in 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 phr review nor the information available suggests a design or manufacturing related cause could be related to the manufacturing process of the unit.Therefore, no corrective or preventive actions will be taken.

• Brand Name: POWERFLEXPRO 4MM4CM 135
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60th ave; miami lakes FL 33014
• MDR Report Key: 10868930
• Report Number: 9616099-2020-04074
• Device Sequence Number: 3766125
• Product Code: LIT
• UDI-Device Identifier: 20705032059159
• UDI-Public: 20705032059159
• 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: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/28/2020

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: 10/31/2020
• Device Model Number: 4400404X
• Device Catalogue Number: 4400404X
• Device Lot Number: 82148335
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/27/2020
• Supplement Date Received by Manufacturer: 10/27/2020
• Initial Report FDA Received Date: 11/19/2020
• Supplement Report FDA Received Date: 12/28/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: BALLOON CATHETER; BALLOON CATHETER