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U.S. Department of Health and Human Services

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

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BOSTON SCIENTIFIC CORPORATION DISPOSABLE PULLBACK SLED FOR MOTORDRIVE COMPUTER, DIAGNOSTIC, PROGRAMMABLE Back to Search Results
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.
 
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Brand NameDISPOSABLE PULLBACK SLED FOR MOTORDRIVE
Type of DeviceCOMPUTER, DIAGNOSTIC, PROGRAMMABLE
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
300 boston scientific way
marlborough MA 01752
MDR Report Key10513940
MDR Text Key206311564
Report Number10513940
Device Sequence Number1
Product Code DQK
Combination Product (y/n)N
Number of Events Reported1
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
0 Patients were Involved in the Event:
Date FDA Received09/10/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberH749A70200
Device Lot NumberS1005591
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA08/25/2020
Event Location Hospital
Date Report to Manufacturer09/10/2020
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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