MAUDE Adverse Event Report: COVIDIEN EVERCROSS 035; CATHETER, PERCUTANEOUS

Model Number AB35W08040080

Device Problem Burst Container or Vessel (1074)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/27/2013

Event Type  malfunction  

Manufacturer Narrative

This mdr is being submitted as a part of a retrospective review / remediation effort performed at the covidien plymouth location, fo llowing medtronic¿s acquisition of covidien.  a capa has been opened to manage the actions related to remediation of complaint files and any required mdr reporting.(b)(4).

Event Description

The physician intended to treat the femoral artery with an evercross balloon.It is reported that he was attempting to inflate the balloon inside a previously implanted stent that had occluded.The balloon burst before reaching nominal pressure.The balloon was removed in tact with no injury to the patient.Summary evaluation: the evercross dilatation catheter was received for evaluation without any ancillary devices.The balloon chamber exhibited a longitudinal tear that extended from the proximal cone to 8mm proximal to the distal marker band.The tear exhibited a slight (incomplete) transverse tail on the distal end.It could not be determined whether the transverse tear was present during the procedure (post-burst) or was generated in the cer evaluation lab while opening the tear-line for photography.The balloon material did not exhibit any inherent material deficiencies that would have contributed to the noted tear.

Manufacturer Narrative

This mdr is being submitted as a part of a retrospective review / remediation effort performed at the covidien (b)(4) location, following medtronic¿s acquisition of covidien.  a capa has been opened to manage the actions related to remediation of complaint files and any required mdr reporting.

• Brand Name: EVERCROSS 035
• Type of Device: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): COVIDIEN; 4600 nathan lane north; plymouth MN 55442
• Manufacturer (Section G): COVIDIEN; 4600 nathan lane north; plymouth MN 55442
• Manufacturer Contact: mary haufek ; 4600 nathan lane north; plymouth, MN 55442 ; 7633987000
• MDR Report Key: 5322005
• MDR Text Key: 34932703
• Report Number: 2183870-2015-07605
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K110319
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 06/28/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 04/23/2016
• Device Model Number: AB35W08040080
• Device Catalogue Number: AB35W08040080
• Device Lot Number: 9738931
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/18/2013
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/28/2013
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/23/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other