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

Model Number	2841
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Codes	Low Blood Pressure/ Hypotension (1914); Injury (2348); Respiratory Failure (2484)
Date of Event	12/24/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that patient experienced hypotension and wire coating peeled off.The target lesion was located in a coronary artery.After advancing the 300cm marvel guidewire, a 3.00 x 20mm synergy ii drug-eluting stent was advanced for treatment.However, the patient experienced low blood pressure.The stent was removed and the wire was repositioned.It was then noticed that the stent was unable to advance over the wire and the tip was dragging the coating material off the wire.The procedure was completed with a different device and no further patient complications 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: 9570730
• Report Number: 2134265-2019-16635
• Device Sequence Number: 2132824
• Product Code: DQX
• UDI-Device Identifier: 08714729881193
• UDI-Public: 08714729881193
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 01/09/2020

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: 05/26/2022
• Device Model Number: 2841
• Device Catalogue Number: 2841
• Device Lot Number: 0023856592
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/24/2019
• Initial Report FDA Received Date: 01/09/2020
• 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: Other