MAUDE Adverse Event Report: CORDIS US. CORP POWERFLEX PRO; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Catalog Number	4400708X
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/23/2023
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, a 7mm x 8cm 135cm powerflex pro percutaneous transluminal angioplasty (pta) balloon catheter was used successfully and was removed to be used later in the procedure.However, upon flushing the balloon catheter prior to re-using it, the catheter shaft burst.The procedure was ended and there was no reported injury to the patient.This occurred during a procedure in which a lower leg arteriogram was performed.The device was stored and prepped per the instructions for use (ifu) and was able to maintain negative pressure during preparation.There were no difficulties removing the sterile packaging components.The initial inflation of the balloon was below the rated burst pressure (rbp).After initial use of the device, the device was coiled and laid flat on the scrub table.The device will be returned for evaluation.
Additional Manufacturer Narrative
A review of the manufacturing documentation associated with lot 82264218 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.Additional information is pending and will be submitted within 30 days upon receipt.
Additional Manufacturer Narrative
Complaint conclusion: as reported, a 7mm x 8cm 135cm powerflex pro percutaneous transluminal angioplasty (pta) balloon catheter was used successfully and was removed to be used later in the procedure.However, upon flushing the balloon catheter prior to re-using it, the catheter shaft burst.The procedure was ended and there was no reported injury to the patient.This occurred during a procedure in which a lower leg arteriogram was performed.The device was stored and prepped per the instructions for use (ifu) and was able to maintain negative pressure during preparation.There were no difficulties removing the sterile packaging components.The initial inflation of the balloon was below the rated burst pressure (rbp).After initial use of the device, the device was coiled and laid flat on the scrub table.The product was returned for analysis.A non-sterile powerflex pro 7mm x 8cm 135 was received coiled inside of a clear plastic bag.The device was unpacked to proceed with the product evaluation.The unit was thoroughly inspected observing that no damages or anomalies were observed during the unaided eye visual inspection.The balloon was received deflated.Functional testing was performed using an inflator/deflator device attached to the inflation port, positive pressure was applied with the purpose of reaching the rated burst pressure.The balloon functioned as intended with no leakage or anomalies noted on the device.A product history record (phr) review of lot 82264218 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The failure reported by the customer as ¿body/shaft burst" was not confirmed during device analysis.The exact cause of the reported event cannot be determined.The device passed functional analysis with no leakage, burst, or damages were noted on the device.Therefore, based on the information available for review, it is difficult to draw a clinical conclusion between the device and the event reported by the customer as no anomalies were noted on the device.According to the safety information in the instructions for use ¿according to the safety information in the instructions for use, ¿flush the ¿thru¿ lumen with sterile heparinized saline or a similar isotonic solution.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.If resistance is met during manipulation, determine the cause of the resistance before proceeding.¿ 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.

• Brand Name: POWERFLEX PRO
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): CORDIS US. CORP; 14201 nw 60 avenue; miami lakes, florida 33014
• Manufacturer (Section G): CORDIS US CORP.; 14201 nw 60 avenue; miami lakes, florida 33014
• Manufacturer Contact: karla castro ; coyol free zone, building b25, , , costa rica; el coyol alajuela bld 25 ; 7863138372
• MDR Report Key: 17483347
• Report Number: 3007635982-2023-00254
• Device Sequence Number: 20528148
• Product Code: LIT
• UDI-Device Identifier: 20705032059746
• UDI-Public: (01)20705032059746(17)251031(10)82264218
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K112797
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/04/2023

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
• Device Expiration Date: 10/31/2025
• Device Catalogue Number: 4400708X
• Device Lot Number: 82264218
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/03/2023
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/14/2023
• Supplement Date Received by Manufacturer: 09/20/2023
• Initial Report FDA Received Date: 08/08/2023
• Supplement Report FDA Received Date: 10/04/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/10/2022
• 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 Age: 82 YR
• Patient Sex: Female