MAUDE Adverse Event Report: CORDIS CORPORATION POWERFLEXPRO 6MM4CM 80; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number	4400604S
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/24/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A review of the manufacturing documentation associated with lot 82220667 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, when the surgeon was attempting to use a powerflexpro 6mm 4cm balloon catheter to expand the narrowed blood vessel/lesion, it was found that the balloon could not be filled due to a leak from the middle section of the balloon.The damage was found after the device was removed intact from the patient and a new balloon was used to complete the procedure.There was no injury to the patient.The product was stored properly according to the instructions for use (ifu).There was no difficulty removing the product from the hoop, removing the protective balloon cover, and no difficulty removing the stylet or any of the sterile packaging components.There were no kinks, or any other damages noted on the device prior to inserting into the patient.The device prepped normally and was able to maintain negative pressure.The lesion was in the basilic vein.The lesion was noted to have a 100% stenosis.The inflation device was filled with a saline/contrast ratio of 1:1.That same inflation device was successfully used with other devices during the procedure.There was no resistance/friction experienced while the balloon catheter was inserted into the rotating hemostatic valve.There was no resistance/friction while inserting the balloon catheter through the guide catheter.The balloon was advanced through the vessel and crossed the lesion without difficulty.The balloon catheter was never in an acute bend nor did the catheter ever kink while being used.Multiple attempts were made without success to obtain the device.

• Brand Name: POWERFLEXPRO 6MM4CM 80
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• MDR Report Key: 12712656
• Report Number: 9616099-2021-05027
• Device Sequence Number: 4489413
• Product Code: LIT
• UDI-Device Identifier: 20705032059517
• UDI-Public: (01)20705032059517(17)240331(10)82220667
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/28/2021

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: 03/31/2024
• Device Model Number: 4400604S
• Device Catalogue Number: 4400604S
• Device Lot Number: 82220667
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/08/2021
• Initial Report FDA Received Date: 10/28/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 56 YR
• Patient Weight: 56