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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION BLAZER PRIME HTD; CARDIAC ABLATION PERCUTANEOUS CATHETER
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BOSTON SCIENTIFIC CORPORATION BLAZER PRIME HTD; CARDIAC ABLATION PERCUTANEOUS CATHETER Back to Search Results
Model Number 87121
Device Problem Material Perforation (2205)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/05/2022
Event Type  malfunction  
Manufacturer Narrative
It was indicated that the device will not be returned for evaluation; therefore, a failure analysis of the complaint device could not be completed.
 
Event Description
It was reported that on opening the packaging, the staff noticed an unsealed shaft (peeling / flaking / shearing) of the blazer prime catheter.A different catheter was used to complete the procedure.No patient complications were reported.The device is not expected to be returned as it was retained by the facility.
 
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Brand Name
BLAZER PRIME HTD
Type of Device
CARDIAC ABLATION PERCUTANEOUS CATHETER
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
300 boston scientific way
marlborough MA 01752
Manufacturer (Section G)
BOSTON SCIENTIFIC CORPORATION
302 parkway, global park
la aurora - heredia
CS  
Manufacturer Contact
timothy degroot
4100 hamline avenue north
dc a330
saint paul, MN 55112
6515826168
MDR Report Key15694055
MDR Text Key306725662
Report Number2124215-2022-43978
Device Sequence Number1
Product Code LPB
Combination Product (y/n)N
Reporter Country CodePL
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 10/28/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/28/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number87121
Device Catalogue Number87121
Device Lot Number0029783550
Was Device Available for Evaluation? No
Date Manufacturer Received10/07/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/18/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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