MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION BLAZER OPEN-IRRIGATED; CARDIAC ABLATION PERCUTANEOUS CATHETER

Model Number	86490
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/23/2022
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
It was reported that lab staff noticed an unknown black substance along the edge of the control knob of a blazer open-irrigated catheter while in the box.No patient or procedure involved.Device will be returned.
Additional Manufacturer Narrative
The device was returned to boston scientific for analysis.Visual inspection noted that it was possible to observe a foreign material along the edge of the steering knob.Confirming the reported event.The pouch of the device was unopened.
Event or Problem Description
It was reported that lab staff noticed an unknown black substance along the edge of the control knob of a blazer open-irrigated catheter while in the box.No patient or procedure involved.Device has been returned for analysis.

• Brand Name: BLAZER OPEN-IRRIGATED
• Common Device Name: 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: 14698912
• Report Number: 2134265-2022-06888
• Device Sequence Number: 17437148
• Product Code: OAD
• UDI-Device Identifier: 08714729862239
• UDI-Public: 08714729862239
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: P150005
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/29/2022

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
• Operator of Device: Other
• Device Expiration Date: 01/02/2025
• Device Model Number: 86490
• Device Catalogue Number: 86490
• Device Lot Number: 0028618259
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/23/2022
• Supplement Date Received by Manufacturer: 07/07/2022
• Initial Report FDA Received Date: 06/15/2022
• Supplement Report FDA Received Date: 07/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/03/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown