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

Catalog Number	AB35W10040080
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	Patient Problem/Medical Problem (2688)
Date of Event	06/26/2019
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
It was reported that the physician was using an evercross pta balloon to treat a moderately calcified, moderately tortuous, fibrous lesion in the mid right subclavian artery.There was no damage noted to the packaging and there were no issues noted when removing the device from the tray/hoop.The device was prepped without issue.A 7fr non-medtronic sheath was used with no embolic protection.The device did not pass through a previously deployed stent, no resistance was encountered nor excessive force used on advancing the device to the target lesion.The device was inflated to 8atm using an inflation device and a mix of saline/contrast as inflation fluid.It was reported that the balloon burst on the first inflation and fragmented.Part of the balloon remained in the patients artery so, an 8x80x80 stent was used to cage it against the vessel wall.A new balloon was used to successfully complete the procedure.No patient injury was reported.
Additional Manufacturer Narrative
The everflex se stent was used successfully to cage the device component against the vessel wall.The procedure was completed with no further issues.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Device evaluation.The catheter was received with the balloon chamber fractured from the distal tip.Visual inspection of the balloon showed a radial burst with the catheter fractured off within the balloon segment.Blood residue was observed within the fractured balloon chamber.Approximately 3.5cm of the balloon remained on the catheter.The working length of the catheter was approximately 78.5cm.The product label specification shows the working length is 80cm.Visual inspection under magnification of the distal edge of the catheter shows the inner guidewire lumen is separated at the distal edge of the proximal radiopaque marker band.The proximal marker band exhibits evidence of been tensely pull distal from its original position.It should be noted the distal portion of the evercrosss device which fractured off within the vessel was not returned for investigation.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: 8748332
• Report Number: 2183870-2019-00353
• Device Sequence Number: 1925357
• Product Code: LIT
• UDI-Device Identifier: 00763000185008
• UDI-Public: 00763000185008
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 09/12/2019

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: 05/31/2022
• Device Catalogue Number: AB35W10040080
• Device Lot Number: A840672
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/08/2019
• Initial Date Received by Manufacturer: 06/26/2019
• Supplement Date Received by Manufacturer: 07/01/2019; 09/11/2019
• Initial Report FDA Received Date: 07/01/2019
• Supplement Report FDA Received Date: 07/05/2019; 09/12/2019
• 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