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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC - MAPLE GROVE IMPULSE GUIDE CATHETER; CATHETER, INTRAVASCULAR, DIAGNOSTIC

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BOSTON SCIENTIFIC - MAPLE GROVE IMPULSE GUIDE CATHETER; CATHETER, INTRAVASCULAR, DIAGNOSTIC Back to Search Results
Model Number H749163913021
Device Problem Occlusion Within Device (1423)
Patient Problem Thrombosis (2100)
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
Same case as: 2134265-2016-03900.It was reported that thrombosis occurred.The target lesion was located in the coronary artery.A 5f 155cm impulse guide catheter was selected for use.During a cardiac catheterization procedure, it was noticed that the impulse guide catheter had caused thrombosis in a few instances.No further patient complications were reported.
 
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Brand Name
IMPULSE GUIDE CATHETER
Type of Device
CATHETER, INTRAVASCULAR, DIAGNOSTIC
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 Key5648041
MDR Text Key44984939
Report Number2134265-2016-03901
Device Sequence Number1
Product Code DQO
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K992142
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Other
Type of Report Initial
Report Date 04/13/2016
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? No
Device Operator Health Professional
Device Model NumberH749163913021
Device Catalogue Number16391-302
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 04/13/2016
Initial Date FDA Received05/11/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Other;
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