MAUDE Adverse Event Report: CORDIS CORPORATION POWERFLEX P3 F5 12X4 80; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number	4202040S
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information is pending and will be submitted within 30 days upon receipt.
Event or Problem Description
As reported, the balloon of a 12mm x 4cm 80cm powerflex p3.035 percutaneous transluminal angioplasty (pta) balloon catheter was unable to be inflated and a leak was observed at the distal balloon tip.There was no reported injury to the patient.Additional information was requested but is unavailable, and the device will not be returned for evaluation.
Event or Problem Description
As reported, the balloon of a 12mm x 4cm 80cm powerflex p3.035 percutaneous transluminal angioplasty (pta) balloon catheter was unable to be inflated and a leak was observed at the distal balloon tip.There was no reported injury to the patient.Additional information was requested but is unavailable, and the device was discarded and will not be returned for evaluation.
Additional Manufacturer Narrative
After further review of additional information: complaint conclusion: as reported, the balloon of a 12mm x 4cm 80cm powerflex p3.035 percutaneous transluminal angioplasty (pta) balloon catheter was unable to be inflated and a leak was observed at the distal balloon tip.There was no reported injury to the patient.Additional information was requested but is unavailable.The device was not returned for evaluation.A product history record (phr) review of lot: 82227796 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿balloon leakage: during positive pressure¿ was not confirmed as the device was not returned for analysis.The exact cause could not be determined.Vessel characteristics, although unknown, may have contributed to the reported event.However, with the limited amount of information provided regarding lesion characteristics and without the return of the device for analysis, it is difficult to draw a clinical conclusion between the device and the event reported.According to the instructions for use, which is not intended as a mitigation of risk, ¿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.¿ neither the phr review nor the product analysis suggests that the event experienced by the customer could be related to the manufacturing process.Therefore, no corrective or preventive action will be taken at this time.

• Brand Name: POWERFLEX P3 F5 12X4 80
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• Manufacturer (Section G): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• Manufacturer Contact: karla castro ; 14201 nw 60 avenue; miami lakes, FL 33014 ; 7863138372
• MDR Report Key: 14073100
• Report Number: 9616099-2022-05533
• Device Sequence Number: 5938608
• Product Code: LIT
• UDI-Device Identifier: 20705032003961
• UDI-Public: (01)20705032003961(17)240731(10)82227796
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K032737
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/02/2022

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: 07/31/2024
• Device Model Number: 4202040S
• Device Catalogue Number: 4202040S
• Device Lot Number: 82227796
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/15/2022
• Supplement Date Received by Manufacturer: 04/22/2022
• Initial Report FDA Received Date: 04/11/2022
• Supplement Report FDA Received Date: 05/03/2022
• Date Device Manufactured: 08/11/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNK.
• Patient Sex: Unknown