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

Catalog Number	AB35W06020135
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/12/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Physician was attempting to use a 6 x 20 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 6 x 20 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.

• Brand Name: EVERCROSS 035
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): COVIDIEN; 4600 nathan lane north; plymouth MN 55442
• MDR Report Key: 8045949
• Report Number: 2183870-2018-00500
• Device Sequence Number: 16512304
• Product Code: LIT
• UDI-Device Identifier: 00821684061572
• UDI-Public: 00821684061572
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K082579
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/04/2021
• Device Catalogue Number: AB35W06020135
• Device Lot Number: A701841
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/12/2018
• Initial Report FDA Received Date: 11/07/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 79 YR
• Patient Weight: 83