MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION MARVEL; CATHETER, GUIDEWIRE

Model Number	2841
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/01/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event: used the first date of the month of the aware date as no event date was provided.
Event or Problem Description
It was reported that guide wire detachment occurred.The target lesion was located in the right coronary artery (rca).After the lesion was wired, the proximal rca was stented and the original wire was inserted into the marginal branch.Another wire was needed down the rca and a 190cm marvel guide wire was then advanced.However, the wire appeared to be behind the stent when trying to remove it and the wire came apart.The wire was snared numerous times and eventually the wire was able to be retrieved from the patient's body.No patient complications nor injuries were reported.

• Brand Name: MARVEL
• Common Device Name: CATHETER, GUIDEWIRE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 8929873
• Report Number: 2134265-2019-10168
• Device Sequence Number: 10826402
• Product Code: DQX
• UDI-Device Identifier: 08714729881179
• UDI-Public: 08714729881179
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K151840
• 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
• Report Date (Section B): 08/26/2019

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: 12/06/2021
• Device Model Number: 2841
• Device Catalogue Number: 2841
• Device Lot Number: 0023001691
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/16/2019
• Initial Report FDA Received Date: 08/26/2019
• 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