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

Catalog Number AB35W06200135

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 10/12/2018

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 a 6x20 evercross device to treat a severely calcified lesion with 99% stenosis in the proximal right superficial femoral artery(sfa).Severe tortuosity was reported.A non-medtronic inflation device was used.Physician used a 6f non -medtronic sheath along with a non-medtronic guidewire.The physician pre-dilated the right common femoral and proximal right sfa with a 3 x 100 nanocross followed by a 4 x 100 nanocross.A hawkone m was used throughout the right common femoral and right proximal sfa.The ifu was followed and the 6x20 evercross device was prepped without issue.It was reported the balloon ruptured at 6atm.The physician upsized to a 7f non-medtronic sheath to remove the ruptured balloon.The balloon was removed and replaced with a 5 x 200 evercross balloon in the proximal sfa.A 7 x 150 everflex stent was placed in the proximal sfa.A 6 x 200 evercross balloon was used as post dilation of the right proximal sfa.When removing the 6 x 200 evercross the balloon ripped off and was stuck in the proximal sfa.The physician tried using a gooseneck snare device but upsizing the sheath from the 6f to the 7f allowed removal of the balloon.When removing the 6f sheath the ruptured balloon was attached to the wire and the wire was removed with the sheath.Images were taken of the 7f sheath, the procedure was then completed using a 6 x 20 fortrex balloon in the proximal sfa, followed by a 7 x 20 fortrex balloon in the right proximal sfa.The physician took a right lower extremity image and everything appeared to be fine so he determined the case was completed.

Manufacturer Narrative

Device evaluation: the evercross dilatation catheter was received in two segments: the proximal segment includes the y-manifold, multi-lumen catheter and terminates at the just distal of the proximal balloon radiopaque marker band; the distal segment includes the inner guidewire lumen, distal radiopaque marker band, and distal tip.Only a small segment of the proximal balloon bond cone was received attached to the proximal segment.Approximate 200mm of balloon chamber material length was not accounted for.The proximal segment inner guidewire lumen exhibits tensile stretching just proximal of the balloon chamber proximal radiopaque marker band and the proximal balloon bond.The distal segment inner guidewire lumen exhibits tensile and torsional stretching along with accordion folding just proximal of the distal balloon radiopaque marker band.The distal segment inner guidewire exhibits approximately 5cm of tensile stretching.Overall the catheter exhibits approximately 7cm of tensile stretching.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: 8045851
• MDR Text Key: 126375486
• Report Number: 2183870-2018-00499
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 00821684061763
• UDI-Public: 00821684061763
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 02/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/07/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/26/2021
• Device Catalogue Number: AB35W06200135
• Device Lot Number: A714452
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/08/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/13/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/27/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 79 YR
• Patient Weight: 83