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

Catalog Number	AB35W06040080
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/26/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
The physician was attempting to treat a lesion using an evercross pta balloon.The procedure used a non-medtronic guidewire.The device was prepped as per the ifu with no issues identified.The device did not pass through a previously deployed stent and no excessive force was used during the advancement of the device.It was reported that physician was unable to remove the balloon device from the guidewire.The guidewire got stuck in the tip of the balloon.The physician was able to pull everything out through the sheath.No interventions were required.No patient injury was reported.
Additional Manufacturer Narrative
Additional information received: the balloon had been inflated at least once.The guidewire became stuck when trying to remove the balloon from the patient.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: 7101498
• Report Number: 2183870-2017-00553
• Device Sequence Number: 1461774
• Product Code: LIT
• UDI-Device Identifier: 00821684061619
• UDI-Public: 00821684061619
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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): 01/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/08/2020
• Device Catalogue Number: AB35W06040080
• Device Lot Number: A505484
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/09/2017
• Supplement Date Received by Manufacturer: 12/12/2017
• Initial Report FDA Received Date: 12/08/2017
• Supplement Report FDA Received Date: 01/09/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1