MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION BLAZER DX-20 DIAGNOSTIC CATHETER; CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING

Model Number	86700
Medical Device Problem Codes	Contamination (1120); Unsealed Device Packaging (1444)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/05/2024
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 prior to an ablation procedure, a blazer dx-20 diagnostic catheter was selected for use.The lab staff found a hole in one of the catheter packages prior to being opened.The hole was in the sterile packaging by the handle of the catheter.Product was not used during the procedure.A new non-damaged catheter was used to completed the procedure.No patient complications were reported.Device is expected to be returned for further analysis.
Event or Problem Description
It was reported that prior to an ablation procedure, a blazer dx-20 diagnostic catheter was selected for use.The lab staff found a hole in one of the catheter packages prior to being opened.The hole was in the sterile packaging by the handle of the catheter.Product was not used during the procedure.A new non-damaged catheter was used to completed the procedure.No patient complications were reported.Device is expected to be returned for further analysis.
Additional Manufacturer Narrative
The device has not been received for analysis.However, an image was reviewed by a boston scientific quality engineer.The image shows evidence of the device packaging being damaged.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.
Additional Manufacturer Narrative
Blazer dx-20 diagnostic catheter was evaluated by boston scientific.The product analysis could not be performed since the device has not returned with the pouch, however, an image was reviewed by a boston scientific quality engineer.The image shows evidence the device packaging was damaged, consequently confirming the reported event since failure might have been caused due to a bad manipulation or wrong handling during the transport of the unit.
Event or Problem Description
It was reported that prior to an ablation procedure, a blazer dx-20 diagnostic catheter was selected for use.The lab staff found a hole in one of the catheter packages prior to being opened.The hole was in the sterile packaging by the handle of the catheter.Product was not used during the procedure.A new non-damaged catheter was used to completed the procedure.No patient complications were reported.Device was returned for further analysis.

• Brand Name: BLAZER DX-20 DIAGNOSTIC CATHETER
• Common Device Name: CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
• 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: angela hinkley ; 4100 hamline avenue north; dc a330; saint paul, MN 55112 ; 6514400979
• MDR Report Key: 20066127
• Report Number: 2124215-2024-53189
• Device Sequence Number: 7821194
• Product Code: DRF
• UDI-Device Identifier: 08714729780496
• UDI-Public: 08714729780496
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K081576
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/25/2024

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: Health Professional
• Device Model Number: 86700
• Device Catalogue Number: 86700
• Device Lot Number: 0033893389
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/05/2024
• Supplement Date Received by Manufacturer: 09/02/2024; 11/01/2024
• Initial Report FDA Received Date: 08/26/2024
• Supplement Report FDA Received Date: 09/23/2024; 11/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/24/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown