MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION MACH1; CATHETER, PERCUTANEOUS

Model Number	H749343566480
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/27/2018
Type of Reportable Event	Malfunction
Event or Problem Description
Snare device broken was in peg kit.

• Brand Name: MACH1
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific corporation; marlborough MA 01752
• MDR Report Key: 7663411
• Report Number: 7663411
• Device Sequence Number: 19335839
• Product Code: DQY
• UDI-Device Identifier: 08714729351771
• UDI-Public: (01)08714729351771
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 06/29/2018
• Report Date (Section F): 06/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: H749343566480
• Device Lot Number: 22266903
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 07/05/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/05/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 06/29/2018