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

Catalog Number	AB35W05040135
Medical Device Problem Code	Device Damaged by Another Device (2915)
Health Effect - Clinical Code	Patient Problem/Medical Problem (2688)
Date of Event	03/15/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Month and year only valid.If information is provided in the future, a supplemental report will be issued.
Event or Problem 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.
Additional 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.
Additional Manufacturer Narrative
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: 8456230
• Report Number: 2183870-2019-00151
• Device Sequence Number: 19555188
• Product Code: LIT
• UDI-Device Identifier: 00821684061398
• UDI-Public: 00821684061398
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/09/2019

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: 01/18/2021
• Device Catalogue Number: AB35W05040135
• Device Lot Number: A583737
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/25/2019
• Supplement Date Received by Manufacturer: 04/04/2019; 10/08/2019
• Initial Report FDA Received Date: 03/27/2019
• Supplement Report FDA Received Date: 05/01/2019; 10/09/2019
• 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
• Patient Age: 72 YR