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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 Problems Unsealed Device Packaging (1444); Tear, Rip or Hole in Device Packaging (2385)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/09/2021
Event Type  malfunction  
Manufacturer Narrative
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 upon opening the outer box of the blazer ii htd catheter, it was noted that there were holes in the plastic packaging covering the catheter, which had clearly breached the sterility of the product.The device was replaced and the procedure was completed successfully.No patient complications occurred.The return of the product is being organized by local customer services.
 
Manufacturer Narrative
The device was not returned to boston scientific for analysis, however media was analyzed.Media inspection of two images showed a device inside of its package and the clear cover of the package showed a hole, located over one wing of the steering handle.Based on the pictures provided, no more damages/defects were found.The lot number printed on the device matched with the lot number reported 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 upon opening the outer box of the blazer ii htd catheter, it was noted that there were holes in the plastic packaging covering the catheter, which had clearly breached the sterility of the product.The device was replaced and the procedure was completed successfully.No patient complications occurred.The return of the product is being organized by local customer services.
 
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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 Key11543836
MDR Text Key241506665
Report Number2134265-2021-03686
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
Report Date 04/22/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/22/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date05/29/2022
Device Model Number85060
Device Catalogue Number85060
Device Lot Number0023879639
Was Device Available for Evaluation? No
Date Manufacturer Received04/06/2021
Patient Sequence Number1
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