MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION BLAZER II HTD; CARDIAC ABLATION PERCUTANEOUS CATHETER

Model Number 85060

Device Problem Tear, Rip or Hole in Device Packaging (2385)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/20/2022

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 the blazer ii htd catheter package was damaged, and the sterile seal was compromised.There was no patient involved.This device is expected to be returned for analysis.

Manufacturer Narrative

The device has not been received for analysis.However, media inspection was performed based on pictures provided by the field.Damage was observed on the label carton and in the sterile barrier of the packaging.It was possible to confirm the reported clinical observations.

Event Description

It was reported that the blazer ii htd catheter package was damaged, and the sterile seal was compromised.There was no patient involved.This device is expected to be returned for laboratory analysis.

• 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
• 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 Key: 14934857
• MDR Text Key: 295406996
• Report Number: 2124215-2022-24393
• Device Sequence Number: 1
• Product Code: LPB
• Combination Product (y/n): N
• Reporter Country Code: PL
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/17/2022

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 Number: 85060
• Device Catalogue Number: 85060
• Device Lot Number: 0029300987
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/23/2022
• Initial Date FDA Received: 07/06/2022
• Supplement Dates Manufacturer Received: 07/21/2022
• Supplement Dates FDA Received: 08/17/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/28/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1