MAUDE Adverse Event Report: CORDIS CORPORATION POWERFLEXPRO 5MM4CM 80; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Catalog Number	4400504S
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/09/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A powerflex pro percutaneous transluminal angioplasty (pta) balloon catheter (5mm x 4cm x 80cm) was inserted for inflation.However, it ruptured at its nominal pressure.There was no reported patient injury.The powerflex pro balloon was replaced with a non-cordis balloon catheter, inflated and the procedure was completed.Initially, this was a shunt anastomosis percutaneous transluminal angioplasty case.The vessel level of calcification is severe.The vessel level of angulation and tortuosity is moderate.The device was prepped normally per the instructions for use (ifu).The contrast to saline ratio was 50:50.The same indeflator was used successfully with other devices.The device was removed intact (in one piece) from the patient and no kink/bent was noted after removal.The product was not returned for analysis.A product history record (phr) review of lot 17684315 revealed no anomalies or non-conformance's 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 could not be determined.Vessel characteristics such as severe calcification may have contributed to the event reported, as calcium is known to damage balloon material.However, the procedure performed was a shunt (pta) case.Arteriovenous shunts are often scarred and fibrous in nature and are therefore often resistant to balloon expansion increasing the likelihood of damage to the balloon.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 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
As reported, a powerflex pro pta balloon catheter (5mm4cm 80) was inserted for inflation.However, it ruptured at its nominal pressure.There was no reported patient injury.Therefore, the powerflex pta balloon was replaced with a non-cordis balloon catheter (5*40) and inflated.The procedure was completed.Initially, this was a shunt anastomosis percutaneous transluminal angioplasty (pta) case.The vessel level of calcification is severe.The vessel level of angulation and tortuosity is moderate.The device was prepped per the instructions for use (ifu).The device was prep normally.The contrast to saline ratio was 50:50.The same indeflator was used successfully with other devices.There were no kink/bent noted after device was removed from patient.The device was removed intact (in one piece) from the patient.There is no procedural film/cd available for review.The device will not be returned for analysis as the device was discarded in the hospital.

• Brand Name: POWERFLEXPRO 5MM4CM 80
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60th ave; miami lakes FL 33014
• MDR Report Key: 8864185
• Report Number: 9616099-2019-03117
• Device Sequence Number: 11282330
• Product Code: LIT
• UDI-Device Identifier: 20705032059326
• UDI-Public: 20705032059326
• 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
• Report Date (Section B): 08/06/2019

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: 05/31/2020
• Device Catalogue Number: 4400504S
• Device Lot Number: 17684315
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/10/2019
• Initial Report FDA Received Date: 08/06/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1