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

Model Number AB35W05080135

Device Problems Burst Container or Vessel (1074); Positioning Problem (3009)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Physician intended to use an evercross pta balloon during treatment of a calcified and plaque lesion in the patient¿s distal common iliac artery and superficial femoral artery. Vessel diameter is reported as 6mm. Lesion exhibited 70% stenosis. Severe vessel calcification and tortuosity are reported. 3 evercross pta balloons are reported to have been used. No damage was noted to the packaging of any of the devices, and no issues were noted during removal from the product packaging. Ifu was followed and the 3 balloons were prepped without issue. A non-medtronic inflation device is reported to have been used for balloon inflation. Embolic protection was not used during the procedure. For the first evercross balloon, it is reported that no resistance was encountered during advancement and the device was not passed through a previously deployed stent. A circumferential/radial balloon burst is reported during balloon inflation at a pressure of 15atm (above rbp). 4 prior inflations had been applied to the device. The device was replaced. For the second evercross pta balloon, it is reported that resistance was encountered during advancement and the device was not passed through a previously deployed stent. A circumferential/radial balloon burst at 15atm is reported for the second evercross balloon also, with 4 inflations having been previously applied. The balloon was replaced with a third evercross pta balloon. A circumferential/radial balloon burst at 16atm is reported for the third balloon during inflation. The device was replaced with a bigger balloon to complete the procedure. In all cases, no balloon fragments were left in the patient. It was also reported the 3 balloons failed to cross the lesion. No patient injury reported.

• Brand Name: EVERCROSS 035
• Type of Device: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): COVIDIEN; 4600 nathan lane north; plymouth MN 55442
• Manufacturer (Section G): COVIDIEN; 4600 nathan lane north; plymouth MN 55442
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; 091708734
• MDR Report Key: 10611676
• MDR Text Key: 209357281
• Report Number: 2183870-2020-00313
• 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: company representative,health

Reporter Occupation

• Type of Report: Initial,Followup,Followup
• Report Date: 12/02/2020

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 10/01/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: AB35W05080135
• Device Catalogue Number: AB35W05080135
• Device Lot Number: B054148
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 12/01/2020
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Date Device Manufactured: 07/15/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial