MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. THERAPY ABLATION CATHETER QUADRIPOLAR, MEDIUM CURVE 7F; CARDIAC ABLATION PERCUTANEOUS CATHETER

Model Number	IBI-83365
Medical Device Problem Codes	Material Frayed (1262); Difficult to Remove (1528); Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/23/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The results/method and conclusion codes along with investigation results will be provided in a subsequent submission.
Event or Problem Description
During the procedure, the catheter was inserted in the usual fashion via arterial sheath.Upon advancement to and from the heart, the catheter looped around itself.The catheter was straightened out successfully and pulled out of the sheath.It was noted that the coating on the shaft had been damaged, which both prevented the deflection mechanism from functioning properly and exposed internal catheter components.The ablation catheter was replaced with a flexibility ablation catheter to complete the procedure with no adverse patient consequences.
Additional Manufacturer Narrative
One quadripolar, therapy ablation catheter was received for evaluation.The reported torn shaft, withdrawal difficulty, deflection issue, and exposed internal components were confirmed.The catheter shaft was noted to be torn, exposing the internal components of the catheter and interfering with the ability to deflect.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 torn shaft remains unknown.

• Brand Name: THERAPY ABLATION CATHETER QUADRIPOLAR, MEDIUM CURVE 7F
• Common Device Name: CARDIAC ABLATION PERCUTANEOUS CATHETER
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.; 2375 morse ave; irvine CA 92614
• MDR Report Key: 11018973
• Report Number: 2030404-2020-00103
• Device Sequence Number: 13670437
• Product Code: LPB
• UDI-Device Identifier: 05414734306928
• UDI-Public: 05414734306928
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: P040014
• 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): 02/18/2021

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: 07/31/2022
• Device Model Number: IBI-83365
• Device Catalogue Number: IBI-83365
• Device Lot Number: 7140788
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/21/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/25/2020
• Supplement Date Received by Manufacturer: 02/15/2021
• Initial Report FDA Received Date: 12/16/2020
• Supplement Report FDA Received Date: 02/18/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1