MAUDE Adverse Event Report: CORDIS CORPORATION POWERFLEXPRO 6MM10CM 80; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number	4400610S
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/03/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was not returned for analysis.A device history record (dhr) review was performed and showed that these lots of products met all the requirements per the applicable manufacturing quality plan.Additional information is pending and will be submitted within 30 days upon receipt.A review of the manufacturing documentation associated with lot 17733286 presented no issues during the manufacturing process that can be related to the reported event.
Event or Problem Description
During use, the powerflex pro balloon catheter ruptured at ten atmosphere (10 atm) during its initial inflation.There was no patient injury.Therefore the balloon was replaced with a new competitor's balloon catheter and the procedure was completed successfully.The lesion was the left superficial femoral artery.The lesion seemed to be heavily calcified.The rate of stenosis was high.An ipsilateral approach was made with a 6f competitor's guiding sheath.A competitor's 0.035 guidewire crossed the lesion and a powerflex pro was deliver to the lesion for pre dilation.However it ruptured at 10 atm during its initial inflation.The device has been discarded in the hospital.
Additional Manufacturer Narrative
During use, the powerflex pro balloon catheter ruptured at ten atmospheres (10 atm) during its initial inflation.There was no patient injury.Therefore, the balloon was replaced with a new competitor's balloon catheter and the procedure was completed successfully.The lesion was the left superficial femoral artery.The lesion seemed to be heavily calcified with a high rate of stenosis.An ipsilateral approach was made with a 6f competitor's guiding sheath.A competitor's 0.035 guidewire crossed the lesion and a powerflex pro was delivered to the lesion for pre dilation.The product was not returned for analysis.A product history record (phr) review of lot 17733286 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 could not be determined.Vessel characteristics of heavy calcification with a high rate of stenosis may have contributed to the reported event, as it is known that calcium may damage balloon material.However, without return of the product for analysis, it is difficult to draw a clinical conclusion between the device and the reported event.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.

• Brand Name: POWERFLEXPRO 6MM10CM 80
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• MDR Report Key: 8855995
• Report Number: 9616099-2019-03114
• Device Sequence Number: 11400089
• Product Code: LIT
• UDI-Device Identifier: 20705032059579
• UDI-Public: 20705032059579
• 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): 08/25/2019

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: 10/31/2020
• Device Model Number: 4400610S
• Device Catalogue Number: 4400610S
• Device Lot Number: 17733286
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/04/2019
• Supplement Date Received by Manufacturer: 08/19/2019
• Initial Report FDA Received Date: 08/02/2019
• Supplement Report FDA Received Date: 08/25/2019
• 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 (5MM*4CM, NSE, GOODMAN); GUIDING SHEATH (6F DESTINATION, TERUMO)