MAUDE Adverse Event Report: CORDIS CORPORATION POWERFLEXPRO 6MM4CM 80; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number	4400604S
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/19/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product was not returned for analysis.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.
Event or Problem Description
During a leriche syndrome balloon kissing case, it was reported that the powerflex balloon catheter ruptured at its nominal pressure.There was no reported patient injury.It is unknown how the procedure completed, however, the procedure was successfully completed.The lesion was unknown.The patient¿s vessel level of tortuosity and calcification was unknown.The rate of stenosis was 100 % (cto).The product was clinically used and will not be returned for analysis.
Additional Manufacturer Narrative
During a leriche syndrome balloon kissing case, it was reported that the powerflex balloon catheter ruptured at its nominal pressure.There was no reported patient injury.It is unknown how the procedure completed, however, the procedure was successfully completed.The lesion was unknown.The patient¿s vessel level of tortuosity and calcification was unknown.The rate of stenosis was 100 %, chronic total occlusion (cto).The device was not returned for analysis.A device history record (dhr) review of lot 17689116 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 of the burst could not be determined.Based on the limited information available for review, vessel characteristics (100% stenosed lesion, cto) may have contributed to the reported event as calcification/resistant lesions may cause damage to a 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.Do not exceed the rated burst pressure recommended on the label.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 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.
Additional Manufacturer Narrative
Additional information was received, the reportability determination remains unchanged.During a leriche syndrome balloon kissing case, it was reported that the powerflex balloon catheter ruptured at its nominal pressure.There was no reported patient injury.It is unknown how the procedure completed, however, the procedure was successfully completed.The lesion was unknown.The patient¿s vessel level of tortuosity and calcification was unknown.The rate of stenosis was 100 % (cto).There were no difficulty inflating the balloon during prep.The product was clinically used and will not be returned for analysis.No other information was provided.The device was not returned for analysis.A device history record (dhr) review of lot 17689116 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 of the burst could not be determined.Based on the limited information available for review, vessel characteristics (100% stenosed lesion, cto) may have contributed to the reported event as calcification/resistant lesions may cause damage to a 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.Do not exceed the rated burst pressure recommended on the label.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 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 6MM4CM 80
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60th avenue; miami lakes FL 33014
• MDR Report Key: 7125476
• Report Number: 9616099-2017-01695
• Device Sequence Number: 19199113
• Product Code: LIT
• UDI-Device Identifier: 20705032059517
• UDI-Public: 20705032059517
• 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: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/02/2018

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 Model Number: 4400604S
• Device Catalogue Number: 4400604S
• Device Lot Number: 17689116
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 11/19/2017
• Initial Date Received by Manufacturer: 11/19/2017
• Supplement Date Received by Manufacturer: 01/04/2018; 01/12/2018
• Initial Report FDA Received Date: 12/18/2017
• Supplement Report FDA Received Date: 01/11/2018; 02/02/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1