MAUDE Adverse Event Report: CORDIS CORPORATION POWERFLEXPRO 7MM4CM 80; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number	4400704S
Medical Device Problem Codes	Burst Container or Vessel (1074); Detachment Of Device Component (1104)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/27/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This device is available for analysis but the engineering report is not yet available. 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
It was reported that the power flex pro ruptured and separated in the patient¿s left iliac artery.The doctor used several medical devices of bigger sizes to try to remove the exploded balloon from the artery, without any success.The separated device was removed from the patient by endovascular path but with a lot of difficulties.There was no patient injury.There were no anomalies noted when removed from the packaging or during prep.An indeflator was used to inflate the balloon.No other information was provided.
Additional Manufacturer Narrative
It was reported that the 7 x 40 mm powerflex pro balloon catheter (bc) ruptured and separated in the patient¿s left iliac artery.The doctor used several medical devices of bigger sizes to try to remove the exploded balloon from the artery without any success.The separated device was removed from the patient by endovascular path but with a lot of difficulties.There was no patient injury.There were no anomalies noted when removed from the packaging or during prep.An indeflator was used to inflate the balloon.No other information was provided.The non-sterile distal part of a powerflex pro 7 mm 4 cm 80 was received inside a plastic bag separated into two sections.Per visual analysis, it was noticed that the balloon presented a rupture/separation.Additionally, the inner body was separated and also the powerflex body shaft was found separated.The proximal section of the powerflex unit was not received for analysis.No other issues were found.The received unit was sent to sem analysis, and results showed that the external surface of balloon presented evidence of scratches near the balloon rupture and it¿s very likely that the same factors that caused the scratch marks on the balloon¿s outer surface could have also contributed to the rupture found on the received balloon.The internal surface and distal marker band did not presented any evidence of damages.The catheter body separated sections presented evidence of elongations.The elongations observed suggest that the device was induced to stretching/pulling events that exceed the material¿s yield strength prior to the separation.No other issues were noted during sem analysis.No other anomalies were found during the analysis.A device history record (dhr) review of lot 17630606 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿balloon burst¿ and ¿balloon separated - in-patient¿ were confirmed through analysis of the returned device.However, the cause of the balloon rupture/separation and shaft separation found could not be conclusively determined during the analysis.Based on the information available for review, lesion characteristics (although unknown) and/or procedural/handling factors may have contributed to the burst and separation reported as evidenced by the scratches found on the balloon¿s external surface and presence of elongations at the area of separation during sem analysis.According to the instructions for use, which is not intended as a mitigation, ¿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.Do not advance or retract the catheter unless the balloon is fully deflated under vacuum.Remove the vacuum (do not apply pressure) and carefully withdraw and remove the catheter.Note: gentle counterclockwise rotation of the balloon may ease withdrawal from the sheath or from the percutaneous entry site.If the balloon cannot be withdrawn through the sheath, withdraw the catheter and sheath as a unit.¿ neither the dhr review nor the product analysis suggests that the event experienced by the customer could be related to the manufacturing process; therefore, no corrective/preventive action will be taken at this time.

• Brand Name: POWERFLEXPRO 7MM4CM 80
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60th ave; miami lakes FL 33014
• MDR Report Key: 6593907
• Report Number: 9616099-2017-01124
• Device Sequence Number: 700313
• Product Code: LIT
• UDI-Device Identifier: 20705032059692
• UDI-Public: 20705032059692
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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
• Report Date (Section B): 06/14/2017

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 Expiration Date: 12/31/2019
• Device Model Number: 4400704S
• Device Catalogue Number: 4400704S
• Device Lot Number: 17630606
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/18/2017
• Distributor Facility Aware Date: 05/03/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 05/03/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/26/2017
• Supplement Report FDA Received Date: 06/14/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention