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

Model Number	M00420SL5550
Medical Device Problem Codes	Difficult to Remove (1528); Positioning Problem (3009); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/06/2023
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 during the ablation procedure the catheter deflection issues occurred and could not be retracted right away.The catheter was inserted through the french pinnacle sheath, and advanced into the heart from the right femoral vein access.Under fluoroscopy it was seen that the catheter was retroflexed, and they attempted to manipulate mechanism, advance, and retract svc back into the femoral lane, but the catheter did not return to straight.Catheter was through the sheath.The catheter stayed stuck and could not be withdrawn at first.They advanced into the heart and pulled back into the femoral vein but did not improve the state.Then, with much effort, the catheter was successfully retracted and removed from the body through the 10f sheath.No patient complications occurred.A different device was used to complete the procedure.The device is expected to be returned for analysis.
Additional Manufacturer Narrative
The returned blazer dx diagnostic catheter was analyzed, passed all tests performed, and exhibited normal device characteristics.The reported event was not confirmed.It was confirmed this device met manufacturing specification prior to distribution and there were no manufacturing deviations which could have contributed to the reported event.There is no evidence that the device was used in a manner inconsistent with the labelled indications/ifu.
Event or Problem Description
It was reported that during the ablation procedure the catheter deflection issues occurred and could not be retracted right away.The catheter was inserted through the french pinnacle sheath, and advanced into the heart from the right femoral vein access.Under fluoroscopy it was seen that the catheter was retroflexed, and they attempted to manipulate mechanism, advance, and retract svc back into the femoral lane, but the catheter did not return to straight.Catheter was through the sheath.The catheter stayed stuck and could not be withdrawn at first.They advanced into the heart and pulled back into the femoral vein but did not improve the state.Then, with much effort, the catheter was successfully retracted and removed from the body through the 10f sheath.No patient complications occurred.A different device was used to complete the procedure.The catheter has been received at boston scientific's post market laboratory where it is awaiting analysis.
Additional Manufacturer Narrative
"**udi related data quality updates only** this report is being filed as a correction in response to an fda request for the complete unique identifier (udi) # and to correct discrepancies with product information in the gudid database.The returned blazer dx diagnostic catheter was analyzed, passed all tests performed, and exhibited normal device characteristics.The reported event was not confirmed.It was confirmed this device met manufacturing specification prior to distribution and there were no manufacturing deviations which could have contributed to the reported event.There is no evidence that the device was used in a manner inconsistent with the labelled indications/ifu.
Event or Problem Description
It was reported that during the ablation procedure the catheter deflection issues occurred and could not be retracted right away.The catheter was inserted through the french pinnacle sheath, and advanced into the heart from the right femoral vein access.Under fluoroscopy it was seen that the catheter was retroflexed, and they attempted to manipulate mechanism, advance, and retract svc back into the femoral lane, but the catheter did not return to straight.Catheter was through the sheath.The catheter stayed stuck and could not be withdrawn at first.They advanced into the heart and pulled back into the femoral vein but did not improve the state.Then, with much effort, the catheter was successfully retracted and removed from the body through the 10f sheath.No patient complications occurred.A different device was used to complete the procedure.The catheter has been received at boston scientific's post market laboratory where it is awaiting 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: timothy degroot ; 4100 hamline avenue north; dc a330; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 18341625
• Report Number: 2124215-2023-70859
• Device Sequence Number: 18244399
• Product Code: DRF
• UDI-Device Identifier: 08714729780496
• UDI-Public: (01)08714729780496(17)260831(10)32345557
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/06/2024

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 Expiration Date: 08/31/2026
• Device Model Number: M00420SL5550
• Device Catalogue Number: M00420SL5550
• Device Lot Number: 0032345557
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/06/2023
• Supplement Date Received by Manufacturer: 01/23/2024; 07/09/2024
• Initial Report FDA Received Date: 12/16/2023
• Supplement Report FDA Received Date: 02/19/2024; 08/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/01/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown