MAUDE Adverse Event Report: CORDIS CORPORATION POWERFLEX P3 F5 6X4 80; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number	4206040S
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/18/2022
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, a 5f 6x4 80 powerflex pro percutaneous transluminal angioplasty (pta) balloon catheter while inside the patient seemed to have a hole immediately although the physician barely put any pressure.A second unknown balloon was used to complete the procedure with no issue and injury.There was no reported patient injury.There was no difficulty removing the stylet or any of the sterile packaging components.The device was stored and prepped as per the instructions for use (ifu).There were no kinks or other damages noted prior to inserting the product the product into the patient.The device was prepped normally, and it did not appear to be deformed.The intended procedure/vessel was an angioplasty of fistula.A non-cordis syringe was used as an inflation device and was used successfully with other devices.The physician believed there was a hole as a fluoroscopy image showed minimal inflation with contrast coming out.The balloon inflated minimally and did not burst.The device was discarded and will not be returned for evaluation.
Additional Manufacturer Narrative
Complaint conclusion: as reported, a 5f 6x4 80 powerflex pro percutaneous transluminal angioplasty (pta) balloon catheter while inside the patient seemed to have a hole immediately although the physician barely put any pressure.A second unknown balloon was used to complete the procedure with no issue and injury.There was no reported patient injury.There was no difficulty removing the stylet or any of the sterile packaging components.The device was stored and prepped as per the instructions for use (ifu).There were no kinks or other damages noted prior to inserting the product the product into the patient.The device was prepped normally, and it did not appear to be deformed.The intended procedure/vessel was an angioplasty of fistula.A non-cordis syringe was used as an inflation device and was used successfully with other devices.The physician believed there was a hole as a fluoroscopy image showed minimal inflation with contrast coming out.The balloon inflated minimally and did not burst.The device was not returned for evaluation as it was discarded.No lot number was provided; therefore, a product history record (phr) review could not be generated.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.¿ there is no evidence that the event was related to a manufacturing issue; therefore, no corrective action will be taken.

• Brand Name: POWERFLEX P3 F5 6X4 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: 14681706
• Report Number: 9616099-2022-05712
• Device Sequence Number: 4855739
• Product Code: LIT
• UDI-Device Identifier: 20705032004432
• UDI-Public: 20705032004432
• 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
• Report Date (Section B): 06/13/2022

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 Model Number: 4206040S
• Device Catalogue Number: 4206040S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/18/2022
• Initial Report FDA Received Date: 06/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: ANOTHER UNKNOWN BALLOON; MEDALLIONS SYRINGE
• Patient Sex: Male