MAUDE Adverse Event Report: ST. JUDE MEDICAL SAFIRE BI-DIRECTIONAL ABLATION CATHETER 4 MM TIP UNIVERSAL TEMPERATURE MONITORI; CARDIAC ABLATION PERCUTANEOUS CATHETER

Model Number	402811
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/08/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Manufacturer report number: 2182269-2021-00076.During an av nodal reentry tachycardia (avnrt) procedure, the catheter tip was noted to be bent prior to ablation.The catheter was replaced, however, the second catheter was also bent, but not inserted into the patient.A third catheter was used to complete the procedure without any consequences to the patient.A procedure delay occurred due to these issues.
Additional Manufacturer Narrative
One 4mm tip, large curl, safire ablation catheter was received for evaluation.The reported bend in the catheter was confirmed.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.Based on the received condition of the device and the information provided, the cause of the bend remains unknown.

• Brand Name: SAFIRE BI-DIRECTIONAL ABLATION CATHETER 4 MM TIP UNIVERSAL TEMPERATURE MONITORI
• Common Device Name: CARDIAC ABLATION PERCUTANEOUS CATHETER
• Manufacturer (Section D): ST. JUDE MEDICAL; 14901 deveau place; minnetonka MN 55345
• MDR Report Key: 12555786
• Report Number: 2182269-2021-00075
• Device Sequence Number: 16467658
• Product Code: LPB
• UDI-Device Identifier: 05414734206020
• UDI-Public: 05414734206020
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: P960016-S014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/13/2021

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: 12/31/2023
• Device Model Number: 402811
• Device Catalogue Number: 402811
• Device Lot Number: 7784994
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/06/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 09/08/2021
• Supplement Date Received by Manufacturer: 10/13/2021
• Initial Report FDA Received Date: 09/30/2021
• Supplement Report FDA Received Date: 10/13/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SAFIRE CATHETER; SAFIRE CATHETER