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

Model Number AB35W08040080

Device Problems Burst Container or Vessel (1074); Difficult to Remove (1528); Detachment of Device or Device Component (2907)

Patient Problem Insufficient Information (4580)

Event Date 04/06/2022

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Physician was attempting to use the evercross pta balloon during procedure to treat superficial femoral artery. A 6fr sheath and 0. 035'' guidewire were used. There was no damage noted to packaging, i. E. Shelf carton, hoop/tray and no issues noted when removing the device from the hoop/tray. The device was prepped per ifu with no issues. It was reported that the balloon burst under low pressure 5-6 atm. The balloon was dislocated completely from the shaft. The balloon couldn't be removed from the vessel, so it had to be trapped with a covered stent in the distal iliac artery. Physician stated that 'normally if i see that a balloon is destroyed, the covering is on the balloon, but in this case it was away'. No patient injury.

• Brand Name: EVERCROSS 035
• Type of Device: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINA
• Manufacturer (Section D): COVIDIEN; 4600 nathan lane north; plymouth MN 55442
• Manufacturer (Section G): COVIDIEN; 4600 nathan lane north; plymouth MN 55442
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 14071599
• MDR Text Key: 291382274
• Report Number: 2183870-2022-00129
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 00643169974296
• UDI-Public: 00643169974296
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K082579
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative

Reporter Occupation

• Type of Report: Initial,Followup,Followup
• Report Date: 07/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/11/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: AB35W08040080
• Device Catalogue Number: AB35W08040080
• Device Lot Number: B282105
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/08/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/15/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No

Patient Treatment Data

Date Received: 04/11/2022 Patient Sequence Number: 1