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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION FATHOM -14; WIRE, GUIDE, CATHETER
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BOSTON SCIENTIFIC CORPORATION FATHOM -14; WIRE, GUIDE, CATHETER Back to Search Results
Model Number 81725
Device Problems Difficult to Insert (1316); Device Contamination with Chemical or Other Material (2944)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/21/2023
Event Type  malfunction  
Event Description
It was reported that device contamination occurred.The target lesion was in the middle cerebral artery.A 200cm x 10cm angled tip fathom-14 guidewire was selected for use.During insertion, a round-shaped foreign material was noted on the tip of the guidewire.Device could not enter the y valve.The procedure was completed with another fathom guidewire.No complications reported and the patient is stable.
 
Manufacturer Narrative
Device evaluated by mfr: the device was returned for evaluation.The guidewire was returned for the analysis, and it was observed that the guidewire was kinked at the distal section.No more damages were detected.No foreign material was observed in the device distal tip.
 
Event Description
It was reported that device contamination occurred.The target lesion was in the middle cerebral artery.A 200cm x 10cm angled tip fathom-14 guidewire was selected for use.During insertion, a round-shaped foreign material was noted on the tip of the guidewire.Device could not enter the y valve.The procedure was completed with another fathom guidewire.No complications reported and the patient is stable.
 
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Brand Name
FATHOM -14
Type of Device
WIRE, GUIDE, CATHETER
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
300 boston scientific way
marlborough MA 01752
Manufacturer (Section G)
BOSTON SCIENTIFIC DE COSTA RICA S.R.L.
302 parkway, global park
la aurora - heredia
CS  
Manufacturer Contact
rachel shields
4100 hamline ave n
arden hills, MN 55112
6512422111
MDR Report Key17515269
MDR Text Key321183666
Report Number2124215-2023-40204
Device Sequence Number1
Product Code DQX
UDI-Device Identifier08714729801030
UDI-Public08714729801030
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K111498
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative,Distributor
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 10/27/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/11/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number81725
Device Catalogue Number81725
Device Lot Number0031072335
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received10/03/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/17/2023
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Age62 YR
Patient SexFemale
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