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

Catalog Number	4400404X
Medical Device Problem Code	Delivered as Unsterile Product (1421)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/20/2024
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 4mm 4cm powerflex pro balloon was not packaged aseptically.After opening the package, it was found that the plastic aseptic package inside was not sealed.There was no reported injury to the patient.The device will not be returned for evaluation as multiple attempts were made without success.
Event or Problem Description
As reported, the 4mm 4cm powerflex pro balloon was not packaged aseptically.After opening the package, it was found that the plastic aseptic package inside was not sealed.There was no reported injury to the patient.The device will not be returned for evaluation as multiple attempts were made without success.
Additional Manufacturer Narrative
After further review of additional information received the following sections have been updated accordingly: b5, d4, g3, g6, h1, h2, h3, h6, and h11.A review of the manufacturing documentation associated with lot 82230304 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 Manufacturer Narrative
As reported, the 4mm x 4cm powerflex pro percutaneous transluminal angioplasty (pta) balloon catheter was not packaged aseptically.After opening the package, it was found that the plastic aseptic package inside was not sealed.There was no reported injury to the patient.The device will not be returned for evaluation as multiple attempts were made without success.The device was returned for analysis.A non-sterile ¿powerflexpro 4mm4cm 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 no damages or anomalies were noted on the received device.The balloon was received deflated and no original packaging was returned with the device.A product history record (phr) review of lot 82230304 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿packaging/pouch/box compromised sterility- seal open¿ cannot be confirmed as the device was returned for analysis in its original packaging, nor procedural images provided.Therefore, the exact cause of the event reported cannot be conclusively determined.Without the return of the device for analysis in its original packaging, we cannot confirm a compromise in sterility.According to the instructions for use, which is not intended as a mitigation of risk, ¿note: do not expose the catheter to organic solvents (e.G.Alcohol).Note: do not use if the inner package is open or damaged.Note: do not resterilize.Exposure to temperatures above 54°c (130°f) may damage the catheter.Note: store in a cool, dark, dry place.Removal from package: open the pouch, grasp the hub and gently take the catheter out.¿ 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.
Event or Problem Description
As reported, the 4mm 4cm powerflex pro balloon was not packaged aseptically.After opening the package, it was found that the plastic aseptic package inside was not sealed.There was no reported injury to the patient.The device will not be returned for evaluation as multiple attempts were made without success.

• Brand Name: POWERFLEX PRO
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): CORDIS US. CORP; 14201 nw 60 avenue; miami lakes FL 33014
• Manufacturer (Section G): CORDIS US CORP.; 14201 nw 60 avenue; miami lakes FL 33014
• Manufacturer Contact: karla castro ; coyol free zone, building b25, , , costa rica; el coyol alajuela bld 25 ; 7863138372
• MDR Report Key: 18702401
• Report Number: 3007635982-2024-00034
• Device Sequence Number: 6223730
• Product Code: LIT
• UDI-Device Identifier: 20705032059159
• UDI-Public: (01)20705032059159(17)240831(10)82230304
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/17/2024

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: 08/31/2024
• Device Catalogue Number: 4400404X
• Device Lot Number: 82230304
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 03/05/2024; 04/08/2024
• Initial Report FDA Received Date: 02/14/2024
• Supplement Report FDA Received Date: 03/27/2024; 04/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/06/2021
• 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: THE BALLOON IS NOT STERILELY PACKAGED
• Patient Sex: Unknown