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

Model Number AB35W06200135

Device Problems Burst Container or Vessel (1074); Deflation Problem (1149); Difficult to Remove (1528)

Patient Problems Obstruction/Occlusion (2422); Embolism/Embolus (4438); Thrombosis/Thrombus (4440)

Event Date 03/26/2022

Event Type  Injury  

Event Description

Physician was attempting to use an evercross pta balloon along with non-medtronic 7fr sheath and 0. 035" stiff wire during procedure to treat a moderately calcified plaque lesion in the left distal common iliac artery. The vessel is moderately tortuous. The vessel diameter and lesion length are 7mm and 250mm respectively. There was no embolic protection used. A non-medtronic inflation device used. A 1/2 nss and 1/2contrast used for inflation fluid. There was no damage noted to packaging. There was no issue noted when removing the device from the hoop/tray. The device was prepped per ifu with no issues identified. It was reported that during balloon inflation, balloon burst occurred at 8atm on first inflation. All fragments of the balloon were retrieved. Removal difficulties occurred with difficulty removing balloon following balloon inflation. The device did not pass through a previously deployed stent. There was no resistance encountered when advancing the device. It was reported that balloon was pulled with force through the sheath after rupture. It was extremely difficult to remove due to balloon rupturing and not completely deflating. Physician reported embolism and thrombus were complications associated with this event. Vessel occlusion also occurred due to the thrombus. No further patient injury reported.

Manufacturer Narrative

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

• 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: 14110061
• MDR Text Key: 289274252
• Report Number: 2183870-2022-00136
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K082579
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 04/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/14/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: AB35W06200135
• Device Catalogue Number: AB35W06200135
• Device Lot Number: B335537
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/14/2022
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Date Device Manufactured: 02/08/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No

Patient Treatment Data

Date Received: 04/14/2022 Patient Sequence Number: 1