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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION IMPULSE; CATHETER, INTRAVASCULAR, DIAGNOSTIC
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BOSTON SCIENTIFIC CORPORATION IMPULSE; CATHETER, INTRAVASCULAR, DIAGNOSTIC Back to Search Results
Model Number 8160
Device Problem Material Integrity Problem (2978)
Patient Problem Vasoconstriction (2126)
Event Date 06/21/2019
Event Type  Injury  
Event Description
It was reported that vasospasm occurred.An impulse 6fr.Fl3.5 diagnostic catheter was selected for use for a coronary angiogram.During procedure, when the catheter was engaged into the left coronary artery, the patient's artery went into spasm.The catheter was disengaged and then re-engaged, but the same event happened to the patient.Moreover, when the catheter was removed from patient it was noted that the 4mm tip of the catheter was quiet stiff and hard.It seemed as if the hydrophilic coating of particular device was not wetting properly.The procedure was completed with a different device.No further patient complications were noted and the patient was stable post procedure.
 
Event Description
It was reported that vasospasm occurred.An impulse 6fr.Fl3.5 diagnostic catheter was selected for use for a coronary angiogram.During procedure, when the catheter was engaged into the left coronary artery, the patient's artery went into spasm.The catheter was disengaged and then re-engaged, but the same event happened to the patient.Moreover, when the catheter was removed from patient it was noted that the 4mm tip of the catheter was quiet stiff and hard.It seemed as if the hydrophilic coating of particular device was not wetting properly.The procedure was completed with a different device.No further patient complications were noted and the patient was stable post procedure.
 
Manufacturer Narrative
(b)(6).Device evaluated by mfr: an impulse diagnostic catheter was returned for analysis.Device analysis of the hub, shaft and tip included microscopic and visual inspection found no damage or defect.The tip of the device was wetted and performed per expectation.There was no indication of any tip defect.
 
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Brand Name
IMPULSE
Type of Device
CATHETER, INTRAVASCULAR, DIAGNOSTIC
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
MDR Report Key8744085
MDR Text Key149499815
Report Number2134265-2019-07576
Device Sequence Number1
Product Code DQO
Combination Product (y/n)N
PMA/PMN Number
K120495
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 09/11/2019
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 Number8160
Device Catalogue Number8160
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/19/2019
Initial Date Manufacturer Received 06/21/2019
Initial Date FDA Received06/28/2019
Supplement Dates Manufacturer Received08/27/2019
Supplement Dates FDA Received09/11/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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