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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 24970
Medical Device Problem Codes Break (1069); Material Deformation (2976)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 05/01/2019
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Age at time of event: 18 years or older.Date of event: populated as (b)(6) 2019 as there is no known event date.Populated as the first day of the month of the bsc aware date (b)(4).
 
Event or Problem Description
It was reported that shaft break occurred.A model-6f pv mach1 was selected for use.However, when the device was taken out from the box, it was found to be separated and bent.The procedure was completed with another of the same device.No patient complication were reported.
 
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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 Key8647175
Report Number2134265-2019-05946
Device Sequence Number14042040
Product Code DQY
UDI-Device Identifier08714729403500
UDI-Public08714729403500
Combination Product (Y/N)N
Initial Reporter CountryJA
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) 05/28/2019
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 Expiration Date08/29/2021
Device Model Number24970
Device Catalogue Number24970
Device Lot Number0060146121
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 05/14/2019
Initial Report FDA Received Date05/28/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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