MAUDE Adverse Event Report: ST. JUDE MEDICAL WORKMATE¿ CLARIS¿ CATHETER INTERFACE MODULE; COMPUTER, DIAGNOSTIC, PROGRAMMABLE

Model Number	H700088
Medical Device Problem Code	Communication or Transmission Problem (2896)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/21/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Related manufacturing ref: 2184149-2024-00009.During a supraventricular tachycardia procedure, there was a communication issue with the ampere rf generator and the workmate catheter interface module resulting in cancellation of the procedure.When the ablation cable was connected to the ampere rf generator, the ablation egm was showing but other egm like the cs, his, and rv showed as flat blue lines.The workmate catheter interface module was exchanged with a secondary one, new ablation cables, and a new catheter were attempted, but the issue remained.The procedure was then cancelled.Replacing the ampere rf generator along with the workmate catheter interface module resolved the issue.
Additional Manufacturer Narrative
One workmate¿ claris¿ catheter interface module 1-56 channels was received.Evaluation testing was successful as the cim communicated properly.Based on the information and investigation provided to abbott, the root cause remains undetermined.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.No non-conformances associated with the reported event were identified.

• Brand Name: WORKMATE¿ CLARIS¿ CATHETER INTERFACE MODULE
• Common Device Name: COMPUTER, DIAGNOSTIC, PROGRAMMABLE
• Manufacturer (Section D): ST. JUDE MEDICAL; one st. jude medical drive; st. paul MN 55117
• Manufacturer (Section G): ST. JUDE MEDICAL; one st. jude medical drive; st. paul MN 55117
• Manufacturer Contact: janna parks ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 18498464
• Report Number: 2184149-2024-00010
• Device Sequence Number: 12715595
• Product Code: DQK
• UDI-Device Identifier: 05415067000880
• UDI-Public: 05415067000880
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K151911
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/06/2024

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 Model Number: H700088
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/22/2023
• Supplement Date Received by Manufacturer: 02/02/2024
• Initial Report FDA Received Date: 01/11/2024
• Supplement Report FDA Received Date: 02/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: AMPERE RF ABLATION GENERATOR.
• Patient Sex: Unknown