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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION BLAZER II HTD; CARDIAC ABLATION PERCUTANEOUS CATHETER
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BOSTON SCIENTIFIC CORPORATION BLAZER II HTD; CARDIAC ABLATION PERCUTANEOUS CATHETER Back to Search Results
Model Number 85060
Device Problem Device Contamination with Chemical or Other Material (2944)
Patient Problem No Patient Involvement (2645)
Event Date 03/01/2020
Event Type  malfunction  
Manufacturer Narrative
Event date is estimated.The device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.
 
Event Description
It was reported that the catheter packaging contained foreign material.Prior to an ablation procedure, before opening up the package of a blazer ii htd ablation catheter, a "red-fluff" like particle was noticed within the unopened package of the device making it a non-sterile product.The "red fluff" was noted near the deflection wing on the handle.The device was never opened and a new catheter was pulled off the shelf and used for the procedure.No patient complications occurred.The device is expected for analysis but has not been received.
 
Manufacturer Narrative
B3.Event date is estimated.The device has not been received for analysis, however, media was returned.Media inspection showed that it seemed that a foreign matter (fiber) was over the steering knob of the device; however, in this image it was difficult/unable to determine if the unit is within it's original sealed pouch.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.
 
Event Description
It was reported that the catheter packaging contained foreign material.Prior to an ablation procedure, before opening up the package of a blazer ii htd ablation catheter, a "red-fluff" like particle was noticed within the unopened package of the device making it a non-sterile product.The "red fluff" was noted near the deflection wing on the handle.The device was never opened and a new catheter was pulled off the shelf and used for the procedure.No patient complications occurred.The device is expected for analysis but has not been received.
 
Manufacturer Narrative
Event date is estimated.The device was returned to boston scientific for evaluation.Visual inspection showed foreign matter (red fiber) near the steering knob of the device.The foreign matter was compared against a size estimation tappi chart and it is bigger than the black comparation dot of 3.00 square millimeters.Media inspection showed the foreign matter (red fiber) observed during analysis, matches with the one of the picture provided by the customer.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.
 
Event Description
It was reported that the catheter packaging contained foreign material.Prior to an ablation procedure, before opening up the package of a blazer ii htd ablation catheter, a "red-fluff" like particle was noticed within the unopened package of the device making it a non-sterile product.The "red fluff" was noted near the deflection wing on the handle.The device was never opened and a new catheter was pulled off the shelf and used for the procedure.No patient complications occurred.The device is expected for analysis but has not been received.
 
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Brand Name
BLAZER II HTD
Type of Device
CARDIAC ABLATION PERCUTANEOUS CATHETER
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
300 boston scientific way
marlborough MA 01752
MDR Report Key9884748
MDR Text Key185205584
Report Number2134265-2020-03932
Device Sequence Number1
Product Code LPB
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup,Followup
Report Date 06/03/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/26/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date12/08/2022
Device Model Number85060
Device Catalogue Number85060
Device Lot Number0024899637
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/15/2020
Date Manufacturer Received05/12/2020
Patient Sequence Number1
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