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

Catalog Number AB35W05040135

Device Problem Device Damaged by Another Device (2915)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 03/15/2019

Event Type  Injury  

Manufacturer Narrative

Month and year only valid.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the an evercross balloon had been used in right superficial femoral artery(sfa).When attempting to withdraw the balloon it appeared to shear off when crossing stents in the right common iliac artery.Multiple manoeuvres were tried to remove the portion of the balloon that had sheared off however, the distal marker could be still seen in the right common iliac artery.The physician elected to trap the broken balloon with a stent.A wire was negotiated past the area and an 8x37 balloon expandable stent was deployed once advanced to the appropriate area.Good blood flow was observed with no evidence of foreign material in the right lower extremity.

Manufacturer Narrative

Additional information: the dislodged fragments were trapped with a visipro stent.No injury to the patient as a result of the dislodged stent.Patient has not required any additional treatment.Patient is stable with no further complications reported.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• Brand Name: EVERCROSS 035
• Type of Device: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): COVIDIEN; 4600 nathan lane north; plymouth MN 55442
• Manufacturer (Section G): COVIDIEN; 4600 nathan lane north; plymouth MN 55442
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; 091708734
• MDR Report Key: 8456230
• MDR Text Key: 140005343
• Report Number: 2183870-2019-00151
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 00821684061398
• UDI-Public: 00821684061398
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K082579
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 10/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/18/2021
• Device Catalogue Number: AB35W05040135
• Device Lot Number: A583737
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/08/2019
• Date Device Manufactured: 01/19/2018
• 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): Required Intervention
• Patient Age: 72 YR