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

Catalog Number	AB35W08040080
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/04/2018
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
The physician used an evercross to treat the superficial femoral artery.Ifu was followed and the device was prepped with no issues noted.It was reported that a balloon burst occurred during inflation.All fragments of the balloon were removed from patient and the procedure was completed used another balloon.No injury reported.
Additional Manufacturer Narrative
Outcome attributed to adverse event updated to: intervention required: type of reportable event updated to: serious injury additional information received: a snare was used for removal of balloon fragments.Evaluation summary: the evercross was returned for evaluation with a 6f sheath.No other ancillary devices were received.The evercross catheter was returned in two segments and the introducer showed no damage or anomalies.The distal tip of the introducer showed traces of dried blood on the walls of the inner diameter of the introducer.Both returned segments of the evercross were evaluated.The distal segment showed the distal marker band intact.The balloon proximal end of the distal balloon segment showed a radial tear.The proximal end of the blue catheter showed buckling.The length of the distal segment was approximately 9cm.The buckling of the proximal end of the fractured catheter was 1 cm.The proximal segment of the returned catheter showed the proximal bond intact and a radial burst of the balloon was noted.The distal edge of the proximal segment was at the distal face of the proximal marker band.The inner was approximately 0.3cm outside of the proximal marker band.The approximate working length for the proximal segment was 76.5cm.The total length of both evercross segments was 85.5cm, which is 5.5cm longer than the indicated working length of 80cm for this device.If information is provided in the future, a supplemental report will be issued.

• 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: 8141395
• Report Number: 2183870-2018-00570
• Device Sequence Number: 11151127
• Product Code: LIT
• UDI-Device Identifier: 00821684062043
• UDI-Public: 00821684062043
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K082579
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/20/2020
• Device Catalogue Number: AB35W08040080
• Device Lot Number: A448569
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/02/2019
• Initial Date Received by Manufacturer: 12/05/2018
• Supplement Date Received by Manufacturer: 12/20/2018
• Initial Report FDA Received Date: 12/07/2018
• Supplement Report FDA Received Date: 01/17/2019
• 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