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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORP. BOSTON SCIENTIFIC RX NEEDLE KNIFE; UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)

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BOSTON SCIENTIFIC CORP. BOSTON SCIENTIFIC RX NEEDLE KNIFE; UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES) Back to Search Results
Model Number 08714729283799
Device Problems Failure to Advance (2524); Physical Resistance/Sticking (4012)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/11/2018
Event Type  malfunction  
Event Description
Guidewire was sticking at the end and we hadn¿t used product.Wire wouldn¿t pass easily.
 
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Brand Name
BOSTON SCIENTIFIC RX NEEDLE KNIFE
Type of Device
UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)
Manufacturer (Section D)
BOSTON SCIENTIFIC CORP.
marlborough MA
MDR Report Key8315465
MDR Text Key136067143
Report NumberMW5083809
Device Sequence Number1
Product Code KNS
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 01/25/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date08/16/2020
Device Model Number08714729283799
Device Catalogue NumberM00545840
Device Lot Number22531520
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received Not provided
Initial Date FDA Received02/06/2019
Was Device Evaluated by Manufacturer? No Information
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Age52 YR
Patient Weight65
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