MAUDE Adverse Event Report: COVIDIEN EVERCROSS 035; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINA

Model Number	AB35W05150135
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/26/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluation the evercross pta balloon returned in its post inflated state visual inspection under a microscope shows a tear on the balloon at approx.4.2cm proximal to the distal tip.Both marker bands are visible and intact.A kink/stretching is noted just proximal to the proximal marker band.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Physician was attempting to use evercross pta balloon during procedure to treat a moderately calcified plaque lesion in the mid superficial femoral artery (sfa) with 70% stenosis.The vessel was little tortuous.A pressure pump was used for balloon inflation.There was no damage noted to packaging.There was no issue noted when removing device from hoop/tray.The device was prepped per ifu with no issues identified.It was reported that balloon inflation difficulties was observed during balloon inflation at 12atm.No balloon burst occurred.No leak present.No balloon damage noted.Balloon was under inflated.The device did not pass through a previously deployed stent.There was no resistance encountered when advancing the device.Balloon was safely removed from patient.Another balloon of the same model was replaced with, and the operation was successfully completed.There was no patient injury.When the device was returned for evaluation, it was noted that the balloon was damaged.

• Brand Name: EVERCROSS 035
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINA
• Manufacturer (Section D): COVIDIEN; 4600 nathan lane north; plymouth MN 55442
• MDR Report Key: 12475261
• Report Number: 2183870-2021-00338
• Device Sequence Number: 14438012
• Product Code: LIT
• UDI-Device Identifier: 00763000184278
• UDI-Public: 00763000184278
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K082579
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 09/15/2021

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: 03/30/2024
• Device Model Number: AB35W05150135
• Device Catalogue Number: AB35W05150135
• Device Lot Number: B184055
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/13/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/15/2021
• Initial Report FDA Received Date: 09/15/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1