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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC - COSTA RICA (HEREDIA) STEEROCATH-DX¿; CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
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BOSTON SCIENTIFIC - COSTA RICA (HEREDIA) STEEROCATH-DX¿; CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING Back to Search Results
Model Number M0042028BL0
Device Problem Device Packaging Compromised (2916)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that there was glue that made the product unsterile.A steerocath-dx catheter was selected for a procedure.However during unpacking it was noticed that there is kind of glue around the outer packaging which is normal but there was glue like in the middle of the plastic right by the product which makes it unsterile when it's opened.The catheter was not used inside of the patient.The procedure was completed with a different device.
 
Event Description
It was reported that there was glue that made the product unsterile.A steerocath-dx catheter was selected for a procedure.However during unpacking it was noticed that there is kind of glue around the outer packaging which is normal but there was glue like in the middle of the plastic right by the product which makes it unsterile when it's opened.The catheter was not used inside of the patient.The procedure was completed with a different device.
 
Manufacturer Narrative
Device evaluated by mfr: unit returned with its original pouch.Analysis of device involved showed a clear foreign matter in the surface of the strain relief.Mtac ftir analysis, the average spectrum for the foreign material presented a spectral match.Foreign material presented non-common peaks and presented no more that 2.03% spectral match with krytox grease.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The investigation conclusion was unable to be determined.(b)(4).
 
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Brand Name
STEEROCATH-DX¿
Type of Device
CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
Manufacturer (Section D)
BOSTON SCIENTIFIC - COSTA RICA (HEREDIA)
302 parkway
la aurora
heredia
CS 
MDR Report Key7560764
MDR Text Key109794984
Report Number2134265-2018-04901
Device Sequence Number1
Product Code DRF
Combination Product (y/n)N
PMA/PMN Number
K924109
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 05/09/2018
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 Model NumberM0042028BL0
Device Catalogue Number2028BL
Device Lot Number0021856537
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/11/2018
Initial Date Manufacturer Received 05/09/2018
Initial Date FDA Received06/01/2018
Supplement Dates Manufacturer Received07/30/2018
Supplement Dates FDA Received08/13/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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