• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

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 Edema (1820); Inflammation (1932)
Event Date 02/04/2015
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 cerebral edema and an inflammatory reaction occurred. During an aneurysm embolization procedure, a mach1 guide catheter was selected. Angiography was then performed in the left internal carotid to treat an intracranial aneurysm. Patient then experienced severe headache just after the intervention. Then, thirty days later, it was reported that the patient had continuous severe headache and had trouble with memory. The magnetic resonance imaging (mri) scan showed cerebral edema and diffused contrast enhancement raising an inflammatory reaction to foreign body "granuloma type" into the catheter holder (left internal carotid). Furthermore, it was observed that the patient had dysexecutive syndrome with psychomotor retardation. Patient then underwent a corticosteroid therapy within three weeks. Patient status was okay; however, the mri still showed a little dose of contrast.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key5111777
MDR Text Key27051758
Report Number2134265-2015-06645
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
Type of Report Initial
Report Date 09/02/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/29/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date09/30/2017
Device MODEL NumberM001197380
Device Catalogue Number19-738
Device LOT Number0050834229
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 Received09/02/2015
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured09/16/2014
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 09/29/2015 Patient Sequence Number: 1
-
-