MAUDE Adverse Event Report: CORDIS CORPORATION POWERFLEXPRO 6MM4CM 135; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number	4400604X
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/09/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This device is available for analysis but has not yet been received.  additional information is pending and will be submitted within 30 days upon receipt.
Event or Problem Description
It was reported that five (5) powerflex pro balloon catheter (bc) burst at ten to twelve atmosphere (10-12 atm) during the intervention in the same patient.There was no patient injury.The device was prep normally.There were no difficulty inflating the balloons during prep. there were no difficulties removing the product from the hoop, the protective balloon cover, the stylet or any of the sterile packaging components.There were no kinks or other damages noted prior to inserting the product the product into the patient.The product was removed intact (in one piece) from the patient.Contrast media used was solutrast 350.The contrast to saline ratio was cm+nacl.The type and brand of inflation device used was arcroyal which was used successfully with other devices.There were no resistance/friction noted while inserting the balloon through the rotating hemostatic valve, guide catheter, and through the vessel.There were no difficulty crossing the lesion.
Additional Manufacturer Narrative
Device history record (dhr) review was conducted and the product met quality requirements for product acceptance.Additional information is pending and will be submitted within 30 days upon receipt.
Additional Manufacturer Narrative
This is one of five products involved with the reported event.(b)(4). it was reported that five (5) powerflex pro balloon catheter (bc) burst at ten to twelve atmosphere (10-12 atm) during the intervention in the same patient.There was no patient injury.The lesion was described as massively calcified.The device was prep normally.There were no difficulty inflating the balloons during prep.There were no difficulties removing the product from the hoop, the protective balloon cover, the stylet or any of the sterile packaging components.There were no kinks or other damages noted prior to inserting the product the product into the patient.The product was removed intact (in one piece) from the patient.Contrast media used was solutrast 350.The contrast to saline ratio was cm and nacl.The type and brand of inflation device used was arcroyal which was used successfully with other devices.There were no resistance/friction noted while inserting the balloon through the rotating hemostatic valve, guide catheter, and through the vessel.There were no difficulty crossing the lesion.The device was not returned for analysis.A device history record (dhr) review of lot 17627139 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 of the bursts reported could not be determined.Based on the limited information available for review, vessel characteristics (massive calcification) may have contributed to the reported event as calcification/resistant lesions may cause damage to the balloon.According to the instructions for use, which is not intended as a mitigation, ¿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.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 reviews nor the information available suggests a design or manufacturing related cause for the reported events.Therefore, no corrective/preventive action will be taken at this time.

• Brand Name: POWERFLEXPRO 6MM4CM 135
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60th ave; miami lakes FL 33014
• MDR Report Key: 6610691
• Report Number: 9616099-2017-01140
• Device Sequence Number: 495179
• Product Code: LIT
• UDI-Device Identifier: 20705032059524
• UDI-Public: 20705032059524
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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: Medical Assistant
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/06/2017

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 Model Number: 4400604X
• Device Catalogue Number: 4400604X
• Device Lot Number: 17627139
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 05/09/2017
• Initial Date Received by Manufacturer: 05/09/2017
• Supplement Date Received by Manufacturer: Not provided; 07/03/2017
• Initial Report FDA Received Date: 06/05/2017
• Supplement Report FDA Received Date: 06/08/2017; 07/06/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1