MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION DISPOSABLE PULLBACK SLED FOR MOTORDRIVE; COMPUTER, DIAGNOSTIC, PROGRAMMABLE

Model Number	H749A70200
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/21/2020
Type of Reportable Event	Malfunction
Event or Problem Description
Middle-aged male with history of coronary artery disease (cad), undergoing an angioplasty and percutaneous coronary intervention (pci).The sled would not record.It was unplugged and it worked fine manually.No known harm to the patient.

• Brand Name: DISPOSABLE PULLBACK SLED FOR MOTORDRIVE
• Common Device Name: COMPUTER, DIAGNOSTIC, PROGRAMMABLE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 10513940
• Report Number: 10513940
• Device Sequence Number: 2555159
• Product Code: DQK
• UDI-Device Identifier: 08714729228684
• UDI-Public: (01)08714729228684(17)210428(10)S1005591
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 08/25/2020
• Report Date (Section F): 08/25/2020

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 Model Number: H749A70200
• Device Lot Number: S1005591
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 09/10/2020
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/10/2020
• 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: 08/25/2020