MAUDE Adverse Event Report: CORDIS CORPORATION POWERFLEXPRO 10MM4CM 80; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number	4401004S
Medical Device Problem Codes	Burst Container or Vessel (1074); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/05/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A review of the manufacturing documentation associated with lot 82189366 presented no issues during the manufacturing process that can be related to the reported event.This device is available for analysis, but the engineering report is not yet available.However, it will be submitted within 30 days upon receipt.
Event or Problem Description
As reported, the powerflex pro 10mm 4cm balloon burst out.There was no reported injury to the patient.The device will be returned for evaluation.Additional information was requested; however, the information was not obtained after multiple attempts.
Additional Manufacturer Narrative
As reported, the powerflex pro 10mm 4cm balloon burst out.There was no reported injury to the patient.Additional information was requested; however, the information was not obtained after multiple attempts.The product was returned for analysis.A non-sterile powerflex pro 10mm x 4cm 80 percutaneous transluminal angioplasty (pta) balloon catheter involved in the complaint was received for analysis inside a plastic bag.Per visual analysis, a separated condition on the inner body of the balloon area was observed; additionally, the balloon was found ruptured/separated (the separated portion of the unit; inner body and distal portion of balloon material, were not returned for evaluation).No other physical characteristics could be seen.Per microscopic analysis, sem analysis was performed to the received separated inner body as well as on the separated/ruptured balloon to identify the possible root cause.Results showed that the powerflex pro complaint unit presented evidence of a burst condition explained in the complaint along with scratch marks located on the external surface of the balloon, this type of damage is commonly caused during the interaction of the material with a sharp object or mechanical damage.It is very likely that the same factors that caused the observed scratch marks on the surface probably led to the damaged condition found on the received device.It seems the material near the damage was ruptured with a sharp object from the outside of the device resulting in the burst of the balloon.No other anomalies were observed during the sem analysis.A product history record (phr) review of lot 82189366 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¿ were confirmed via device analysis and by visual analysis as received; however, the exact cause could not be determined.The device was returned with the balloon rupture/separated.Microscopic analysis revealed scratch marks adjacent to the rupture/damage noted on the balloon/inner body.It is likely vessel characteristics, although unknown, procedural factors and handling of the device contributed to the events reported as evidenced by device analysis.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.Carefully advance the catheter to the selected stenosis.Caution: if strong resistance is met during advancement or withdrawal of the catheter, discontinue movement and determine the cause of resistance before proceeding.If the cause of resistance cannot be determined, withdraw the entire system.When an acceptable position has been obtained, inflate the balloon to achieve the desired dilatation.Caution: do not exceed the rated burst pressure.Higher pressures may damage the balloon or catheter or overdistend the selected artery.Warning: inflation at a high rate may damage the balloon.¿ neither the phr nor the information available suggests a design or manufacturing related cause for the reported event.Therefore, no corrective or preventive action will be taken at this time.
Additional Manufacturer Narrative
After further review of additional information received the following sections have been updated accordingly: b4, g3, h1, h2, h3 and h6 this device is available for analysis, but the engineering report is not yet available.However, it will be submitted within 30 days upon receipt.
Event or Problem Description
As reported, the powerflex pro 10mm 4cm balloon burst out.There was no reported injury to the patient.The device will be returned for evaluation.Additional information was requested; however, the information was not obtained after multiple attempts.Balloon separation was found during the product evaluation.

• Brand Name: POWERFLEXPRO 10MM4CM 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: 15526002
• Report Number: 9616099-2022-06038
• Device Sequence Number: 5990975
• Product Code: LIT
• UDI-Device Identifier: 20705032060056
• UDI-Public: (01)20705032060056(17)230331(10)82189366
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/21/2022

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: 03/31/2023
• Device Model Number: 4401004S
• Device Catalogue Number: 4401004S
• Device Lot Number: 82189366
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/20/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/05/2022
• Supplement Date Received by Manufacturer: 10/13/2022; 11/15/2022
• Initial Report FDA Received Date: 10/01/2022
• Supplement Report FDA Received Date: 11/07/2022; 11/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2020
• 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
• Patient Sex: Unknown