MAUDE Adverse Event Report: CORDIS CORPORATION POWERFLEXPRO 9MM4CM 135; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number	N/A
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/10/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A review of the manufacturing documentation associated with lot 82189361 presented no issues during the manufacturing process that can be related to the reported event.Additional information is pending and will be submitted within 30 days upon receipt.
Event or Problem Description
As reported, a 9mm x 4cm x 135cm powerflex pro percutaneous transluminal angioplasty (pta) balloon catheter was used, but it ruptured due to severe calcification.There was no reported patient injury.The device was opened in the sterile field.The device was stored and prepped as per the instructions for use (ifu).The device was used for an endovascular therapy (evt) case.The target lesion was the iliac artery.Other procedural details were requested but are unknown, unavailable, or not applicable.The device will not be returned for evaluation as it was discarded by a mistake.
Additional Manufacturer Narrative
Complaint conclusion: a 9mm x 4cm x 135cm powerflex pro percutaneous transluminal angioplasty (pta) balloon catheter was used, but it ruptured due to severe calcification.There was no reported patient injury.The device was opened in the sterile field.The device was stored and prepped as per the instructions for use (ifu).The device was used for an endovascular therapy (evt) case.The target lesion was the iliac artery.Other procedural details were requested but are unknown, unavailable, or not applicable.The product was not returned for analysis.A product history record (phr) review of lot 82189361 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿balloon burst¿ could not be confirmed as the device was not returned for analysis.The exact cause could not be determined.Vessel characteristics of severe calcification may have contributed to the reported event as calcification is known to damage balloons.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 limited 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 9MM4CM 135
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• MDR Report Key: 12126777
• Report Number: 9616099-2021-04689
• Device Sequence Number: 19739082
• Product Code: LIT
• UDI-Device Identifier: 20705032059944
• UDI-Public: 20705032059944
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K112797
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (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): 07/09/2021

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: 02/28/2023
• Device Model Number: N/A
• Device Catalogue Number: 4400904X
• Device Lot Number: 82189361
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/10/2021
• Supplement Date Received by Manufacturer: 07/08/2021
• Initial Report FDA Received Date: 07/07/2021
• Supplement Report FDA Received Date: 07/09/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1