MAUDE Adverse Event Report: CORDIS CORPORATION POWERFLEXPRO 6MM15CM 80; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number	4400615S
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/01/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This is one of two reports submitted for the same event.Concomitant medical products: sheath (6f 26cm parent, medikit).A guidewire (radifocus, terumo), guidewire (cruise, asahi intecc) and a new balloon catheter (6 mm nse, goodman).Additional information is pending and will be submitted within 30 days upon receipt.
Event or Problem Description
As reported, the 6mm x 15cm x 80cm powerflex pro percutaneous transluminal angioplasty (pta) balloon catheter was used but it ruptured at 12 atmospheric pressure (atm) during its second inflation.Therefore, another powerflex pro (6mm x 10cm x 80cm) was used but it ruptured at 10 atm during its initial inflation.A new 6mm balloon catheter (non-cordis) was used and it inflated at the lesion.The procedure was completed.There was no reported patient injury.The lesion was the right superficial femoral artery which had severe calcification and continuous stenosis.An ipsilateral approach was made from the right femoral artery with a non-cordis sheath (6f 26cm).A non-cordis guidewire crossed the lesion.The guidewire was replaced with another non-cordis guidewire.The devices will not be returned for analysis as devices were discarded in the hospital.
Additional Manufacturer Narrative
This is one of two reports submitted for the same event.Please reference mfr report #: 9616099-2020-03922.Complaint conclusion: as reported, the 6mm x 15cm x 80cm powerflex pro percutaneous transluminal angioplasty (pta) balloon catheter was used but it ruptured at 12 atmospheric pressure (atm) during its second inflation.Therefore, another powerflex pro (6mm x 10cm x 80cm) was used but it ruptured at 10 atm during its initial inflation.A new 6mm balloon catheter (non-cordis) was used and it inflated at the lesion.The procedure was completed.There was no reported patient injury.The lesion was the right superficial femoral artery which had severe calcification and continuous stenosis.An ipsilateral approach was made from the right femoral artery with a non-cordis sheath (6f 26cm).A non-cordis guidewire crossed the lesion.The guidewire was replaced with another non-cordis guidewire.The product was not returned for analysis as it was discarded in the hospital.A product history record (phr) review of lot 82151215 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 devices were not returned for analysis.The exact cause could not be determined.Vessel characteristics of severe calcification with continuous stenosis, may have contributed to the reported events, as it is known that calcium may damage balloon material.However, without return of the products for analysis, it is difficult to draw a clinical conclusion between the devices and the reported events.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 or preventive action will be taken at this time.

• Brand Name: POWERFLEXPRO 6MM15CM 80
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• MDR Report Key: 10579501
• Report Number: 9616099-2020-03921
• Device Sequence Number: 19695324
• Product Code: LIT
• UDI-Device Identifier: 20705032059609
• UDI-Public: 20705032059609
• 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,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/08/2020

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: 01/31/2021
• Device Model Number: 4400615S
• Device Catalogue Number: 4400615S
• Device Lot Number: 82151215
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/01/2020
• Supplement Date Received by Manufacturer: 09/29/2020
• Initial Report FDA Received Date: 09/24/2020
• Supplement Report FDA Received Date: 10/08/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1