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

Model Number H749A70200

Device Problem Failure to Transmit Record (1521)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/21/2020

Event Type  malfunction  

Event 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
• Type of Device: COMPUTER, DIAGNOSTIC, PROGRAMMABLE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 10513940
• MDR Text Key: 206311564
• Report Number: 10513940
• Device Sequence Number: 1
• Product Code: DQK
• UDI-Device Identifier: 08714729228684
• UDI-Public: (01)08714729228684(17)210428(10)S1005591
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 08/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/10/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: H749A70200
• Device Lot Number: S1005591
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/25/2020
• Event Location: Hospital
• Date Report to Manufacturer: 09/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 17885 DA