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

Model Number AB35W06040080

Device Problems Burst Container or Vessel (1074); Fracture (1260); Difficult to Remove (1528); Detachment of Device or Device Component (2907); Physical Resistance/Sticking (4012)

Patient Problem Rupture (2208)

Event Date 11/14/2019

Event Type  Injury  

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 with a 6fr sheath and 0. 035 non-medtronic wire during treatment of a fibrous lesion in a proximal right upper arm fistula graft. Vessel diameter reported as 6mm. Lesion exhibited 90% stenosis. Slight tortuosity reported. Ifu was followed. No packaging issues noted prior to use. No issues noted when removing the device from the packaging. The device was prepped without issue. The device was not passed through a previously deployed stent. Resistance was encountered during advancement, but no excessive force was used. An inflation device was used with 1:3, contrast: saline mix for balloon inflation. It is reported that a circumferential/radial balloon burst occurred during first inflation at pressure of 14atm. The balloon remained on the wire. The sheath was upsized to 9fr and a snare was advanced down beside existing wire and snare end of wire and pull everything out together. It is believed that the staples from placement of synthetic graft may have been what ruptured the balloon. Slight resistance was felt while trying to remove balloon after rupture. Gentle pressure was applied as resistance is expected with a ruptured balloon. Once the balloon was removed it was discovered that the catheter had fractured and that the distal segment was still in the patient and could be seen under fluoroscopic imaging. A non-medtronic pta balloon was used which also ruptured and ruptured the vessel. A non-medtronic stent was then used to cover the ruptured segment.

Manufacturer Narrative

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

Manufacturer Narrative

Additional information: the fractured segment of the evercross catheter was removed using a snare. All fragments of the evercross balloon were removed from the patient. If information is provided in the future, a supplemental report will be issued.

• 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: 9327539
• MDR Text Key: 168598841
• Report Number: 2183870-2019-00542
• 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,Followup
• Report Date: 02/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: AB35W06040080
• Device Catalogue Number: AB35W06040080
• Device Lot Number: A888211
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/25/2019
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 02/07/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/26/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No

Type of Device Usage

Patient Treatment Data

Date Received: 11/15/2019 Patient Sequence Number: 1