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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION MACH1; CATHETER, PERCUTANEOUS
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BOSTON SCIENTIFIC CORPORATION MACH1; CATHETER, PERCUTANEOUS Back to Search Results
Model Number 1260
Medical Device Problem Codes Detachment of Device or Device Component (2907); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code Hematoma (1884)
Date of Event 07/18/2019
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
(b)(4).
 
Event or Problem Description
It was reported there was difficulty removing the catheter and a patient hematoma occurred.A 6f mach1 guide catheter was selected for an angioplasty procedure.During the procedure, the proximal end of the catheter, external to the patient, popped off.It became very difficult to remove from the patient.However, the catheter was able to be removed from the patient.The patient sustained a minor groin hematoma.
 
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Brand Name
MACH1
Common Device Name
CATHETER, PERCUTANEOUS
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
MDR Report Key8929936
Report Number2134265-2019-10157
Device Sequence Number290919
Product Code DQY
UDI-Device Identifier08714729351887
UDI-Public08714729351887
Combination Product (Y/N)N
Initial Reporter CountryUK
PMA/510(K) Number
K020028
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 08/26/2019
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 Date11/30/2019
Device Model Number1260
Device Catalogue Number1260
Device Lot Number0060029743
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 08/02/2019
Initial Report FDA Received Date08/26/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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