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

Catalog Number	AB35W05020135
Medical Device Problem Codes	Burst Container or Vessel (1074); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Injury (2348)
Date of Event	10/01/2019
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 used evercross pta balloon catheter along with non medtronic 7fr sheath and.035 guide wire to treat a none calcified soft tissue lesion in the right proximal iliac common artery.The vessel diameter was 8mm and severely tortuous.Negative prep was performed.A non-medtronic inflation device was used with inflation fluid.There was no damage noted to packaging and no issues noted when removing the device from the hoop/tray.The device was prepped per the ifu with no issues identified.It was reported that the balloon was used to treat the aortic bifurcation to help crossover kissing stents.The balloon was inflated to 6-7atm and it burst.The balloon is thought to have gone through a stent strut and upon removal was caught on strut.Make and model of previously deployed stent is unknown.The balloon tip was detached during removal and snare used to remove detached component.
Additional Manufacturer Narrative
Product analysis: the evercross was returned with no ancillary devices.The evercross was returned and observed the catheter was fractured apart at the balloon segment of the catheter.A radial balloon burst was observed.The distal portion which fractured off was approximately 4.5cm long.The distal and proximal marker bands were identified.At the proximal marker band, the catheter shaft was buckled and evidence of a ductile fracture.A portion of the balloon was returned which was approximately 1.5 cm was noted.The proximal segment of the catheter showed approximately 1.5cm of the proximal area of the balloon attached.The balloon burst was radial.Image review: the customer provided 3 cine images from the procedure.The images have been evaluated.The evercross device was not identified within the vessel however, implanted stents placed in succession next to one another were identified.The tantalum markers of the distal and proximal edges of the stents were identified.An inserted guide wire was also identified within the vessel.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: 9162008
• Report Number: 2183870-2019-00480
• Device Sequence Number: 2119801
• Product Code: LIT
• UDI-Device Identifier: 00763000184087
• UDI-Public: 00763000184087
• 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,Followup
• Report Date (Section B): 01/15/2020

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: 07/22/2022
• Device Catalogue Number: AB35W05020135
• Device Lot Number: A869117
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/11/2019
• Initial Date Received by Manufacturer: 10/01/2019
• Supplement Date Received by Manufacturer: 01/09/2020
• Initial Report FDA Received Date: 10/07/2019
• Supplement Report FDA Received Date: 01/15/2020
• 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: 68 YR
• Patient Weight: 95