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

Catalog Number	AB35W06150135
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/06/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
The physician attempted to use an evercross balloon with a non-medtronic 6 f sheath and guidewire to treat a moderately calcified 150mm lesion with 40% stenosis in the proximal superficial femoral artery (sfa).The vessel presented minimal tortuosity.The artery diameter was 6mm.Ifu was followed and the device was prepped with no issues.An inflation device was used.It was reported that a longitudinal burst occurred during inflation of the balloon at 10 atm.The balloon was retrieved successfully from patient and the procedure was completed using a chocolate balloon.There was no patient injury reported.
Additional Manufacturer Narrative
Additional information received.The balloon and catheter were removed together through the sheath and no parts embolised in the patient.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Device evaluation: the evercross catheter was returned inside a previously opened evercross pouch which indicated lot a719763.No ancillary devices were included.The evercross catheter was removed from the pouch and inspected.The balloon was in a post-inflated state.Dried blood was noted on the outside and within the balloon.It was observed the balloon showed a longitudinal tear which started approximately 4cm from the distal tip and continued for approximately 9cm (13cm from the distal tip).No other damages were observed to the evercross.A longitudinal tear has been identified.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: 8154820
• Report Number: 2183870-2018-00578
• Device Sequence Number: 2324507
• Product Code: LIT
• UDI-Device Identifier: 00821684061749
• UDI-Public: 00821684061749
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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,Followup,Followup
• Report Date (Section B): 02/01/2019

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: 10/07/2021
• Device Catalogue Number: AB35W06150135
• Device Lot Number: A719763
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/18/2018
• Initial Date Received by Manufacturer: 12/10/2018
• Supplement Date Received by Manufacturer: 12/13/2018; 01/11/2019
• Initial Report FDA Received Date: 12/12/2018
• Supplement Report FDA Received Date: 01/04/2019; 02/01/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1