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

Catalog Number	4400604S
Medical Device Problem Code	Deflation Problem (1149)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/04/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A review of the manufacturing documentation associated with lot 82278877 presented no issues during the manufacturing process that can be related to the reported event.Additional information is pending and will be submitted within 30 days upon receipt.
Event or Problem Description
As reported, the inflation of a 6mm x 4cm powerflex pro percutaneous transluminal angioplasty (pta) balloon catheter was remarkably slow.As a result, the device was deflated and removed; however, the deflation of the device was remarkably slow as well.The device was replaced with a 6mm x 4cm saberx pta balloon catheter to complete the procedure.There were no reported injuries to the patient.This was during and endovascular therapy (evt) procedure to treat a 90% stenosed superficial femoral artery (sfa) lesion which had mild calcification and mild tortuosity.The lesion was not a chronic total occlusion (cto).The device was stored and prepped per the instructions for use (ifu) and there were no difficulties removing any of the sterile packaging components.The device maintained negative pressure during preparation.A non-cordis guidewire was used, and the powerflex pro pta balloon catheter was advanced along the non-cordis guidewire prior to its attempted inflation.The balloon was inflated to 8 atmospheres (atm) via an unknown inflation device and was able to be fully deflated prior to its removal.The device remained in one piece during its removal from the patient.The device will not be returned for evaluation.
Additional Manufacturer Narrative
Complaint conclusion: as reported, the inflation of a 6mm x 4cm powerflex pro percutaneous transluminal angioplasty (pta) balloon catheter was remarkably slow.As a result, the device was deflated and removed; however, the deflation of the device was remarkably slow as well.The device was replaced with a 6mm x 4cm saberx pta balloon catheter to complete the procedure.There were no reported injuries to the patient.This was during and endovascular therapy (evt) procedure to treat a 90% stenosed superficial femoral artery (sfa) lesion which had mild calcification and mild tortuosity.The lesion was not a chronic total occlusion (cto).The device was stored and prepped per the instructions for use (ifu) and there were no difficulties removing any of the sterile packaging components.The device maintained negative pressure during preparation.A non-cordis guidewire was used, and the powerflex pro pta balloon catheter was advanced along the non-cordis guidewire prior to its attempted inflation.The balloon was inflated to eight atmospheres (atm) via an unknown inflation device and was able to be fully deflated prior to its removal.The device remained in one piece during its removal from the patient.The device was not returned for analysis.A product history record (phr) review of lot 82278877 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿balloon inflation difficulty partial or slow¿ and ¿balloon deflation difficulty partial or slow¿ were not confirmed as the device was not returned for analysis.The exact cause of the reported events could not be determined.The vessel was noted to have mild calcification with tortuosity and 90% stenosis which may have contributed to the failure noted.Additionally, we do not know the contrast to saline ratio as this information was not provided.Therefore, without the return of the device for analysis, it is difficult to draw a clinical conclusion between the device and the events reported.According to the instructions for use, which is not intended as a mitigation of risk, ¿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.Use only the recommended balloon inflation medium (a 50/50 mixture by volume of contrast medium and normal saline).Never use air or any gaseous medium to inflate the balloon.Flush the ¿thru¿ lumen with sterile heparinized saline or a similar isotonic solution.Place the prepared catheter over a prepositioned guidewire and advance the tip to the introduction site.Note: balloon inflation should be performed with the guidewire extended beyond the catheter tip.It is strongly recommended that the guidewire, the balloon catheter, or both, remain across the lesion until the procedure is complete and the dilatation system is to be removed from the vessel.Note: to preserve the folded balloon shape during insertion and catheter manipulation, maintain a vacuum on the inflation lumen.Caution: fully deflate the balloon by inducing negative pressure with the inflation system whenever the pta catheter is advanced or withdrawn.Do not advance or withdraw the pta catheter within the vasculature unless the catheter is preceded by a guidewire.Carefully advance the catheter through a sheath or guide catheter through the percutaneous entry site.Note: gentle counterclockwise rotation of the balloon may ease introduction through the sheath or percutaneous entry site.Note: perform all further catheter manipulations under fluoroscopy.Deflate the balloon by pulling vacuum on the inflation syringe or inflation device.Remove the vacuum (do not apply pressure) and carefully withdraw and remove the catheter.Note: gentle counterclockwise rotation of the balloon may ease withdrawal from the sheath or from the percutaneous entry site.If the balloon cannot be withdrawn through the sheath, withdraw the catheter and sheath as a unit.If the cause of resistance cannot be determined, withdraw the entire system.¿ 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: 18245234
• Report Number: 3007635982-2023-00336
• Device Sequence Number: 17939997
• Product Code: LIT
• UDI-Device Identifier: 20705032059517
• UDI-Public: (01)20705032059517(17)260228(10)82278877
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 12/07/2023

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: 02/28/2026
• Device Catalogue Number: 4400604S
• Device Lot Number: 82278877
• Was Device Available for Evaluation?: No
• 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: 11/06/2023
• Supplement Date Received by Manufacturer: 12/04/2023
• Initial Report FDA Received Date: 12/01/2023
• Supplement Report FDA Received Date: 12/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/16/2023
• 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: 6MM X 4CM SABERX PTA BALLOON CATHETER.; RADIFOCUS, TERUMO.
• Patient Sex: Unknown