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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC - MAPLE GROVE MACH1 GUIDE CATHETER CATHETER, PERCUTANEOUS

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BOSTON SCIENTIFIC - MAPLE GROVE MACH1 GUIDE CATHETER CATHETER, PERCUTANEOUS Back to Search Results
Model Number M001197380
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Inflammation (1932); Reaction (2414)
Event Date 06/25/2015
Event Type  Injury  
Manufacturer Narrative

Device evaluated by mfr: it is indicated that the device will not be returned for evaluation. A review of the batch history, historical trending, and similar complaint trending review for the product family will be conducted. If there is any further relevant information from that review, a supplemental medwatch will be filed. (b)(4).

 
Event Description

It was reported that an inflammatory reaction occurred. A mach1 guide catheter was selected to treat an aneurysm. After the embolization of an intracranial aneurysm on a case of a granulomatous meningitis, patient had an inflammatory reaction. Furthermore, regression of motor deficit was observed with the patient under corticosteroid therapy as medical intervention.

 
Manufacturer Narrative

Updated: manufacturing site name. (b)(4).

 
Event Description

It was reported that an inflammatory reaction occurred. A mach1 guide catheter was selected to treat an aneurysm. After the embolization of an intracranial aneurysm on a case of a granulomatous meningitis, patient had an inflammatory reaction. Furthermore, regression of motor deficit was observed with the patient under corticosteroid therapy as medical intervention.

 
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Brand NameMACH1 GUIDE CATHETER
Type of DeviceCATHETER, PERCUTANEOUS
Manufacturer (Section D)
BOSTON SCIENTIFIC - MAPLE GROVE
one scimed place
maple grove MN 55311
Manufacturer (Section G)
AVAIL MEDICAL PRODUCTS INCORPORATED
5950 nancy ridge drive
san diego CA 92121
Manufacturer Contact
linda leimer
one scimed place
maple grove, MN 55311
7634941700
MDR Report Key5081198
MDR Text Key25991996
Report Number2134265-2015-06256
Device Sequence Number1
Product Code DQY
Combination Product (Y/N)N
Reporter Country CodeFR
PMA/PMN NumberK020028
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Initial,Followup
Report Date 08/21/2015
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received09/16/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date03/31/2018
Device MODEL NumberM001197380
Device Catalogue Number19-738
Device LOT Number0050875292
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/30/2015
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured03/31/2015
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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