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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
Device Problem Device Contamination with Chemical or Other Material (2944)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 03/19/2020
Event Type  malfunction  
Event Description
It was reported that foreign matter was present on the device. A 6f vl3. 5 mach1 guide catheter was selected for use. Prior to use, the physician noticed an object that forms like a blood adhered on both the product and the packing list. No patient complications were reported.
 
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Brand NameMACH1
Type of DeviceCATHETER, PERCUTANEOUS
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
Manufacturer (Section G)
FLEXTRONICS INTERNATIONL EUROPE B V
noblestraat 10 14
oostrum lb 5807 GA
NL 5807 GA
Manufacturer Contact
jay johnson
two scimed place
maple grove, MN 55311
7634942574
MDR Report Key9953148
MDR Text Key187524949
Report Number2134265-2020-04912
Device Sequence Number1
Product Code DQY
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K020028
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/27/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/13/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number1260
Device Catalogue Number1260
Device Lot Number0060211783
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/15/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/14/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/18/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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