MAUDE Adverse Event Report: ST. JUDE MEDICAL CARDIAC ABLATION GENERATOR 1641 CABLE (CATHETER TO GENERATOR); CARDIAC ABLATION PERCUTANEOUS CATHETER

Model Number IBI-85641

Device Problem High impedance (1291)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/20/2021

Event Type  malfunction  

Event Description

During a wolff-parkinson-white syndrome ablation procedure, a prolonged procedure occurred due to a high impedance and the troubleshooting involved in order to resolve the issue.Following mapping of the accessory pathway, the 1641 cable connector was inserted into the catheter and a high impedance message was observed.Multiple troubleshooting steps were conducted, but the issue remained.The 1641 cable was replaced and the issue was resolved.There were no adverse consequences to the patient.

Manufacturer Narrative

Additional information: g3, h2, h3, h6 the results of the investigation are inconclusive since the device was not returned for analysis.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.Based on the information received, the cause of the reported high impedance could not be conclusively determined.

Manufacturer Narrative

One 1641 connecting cable was received for evaluation.The cable displayed continuity for each pin with no open or short circuits detected.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the reported impedance issue and subsequent procedure delay remains unknown.

• Brand Name: CARDIAC ABLATION GENERATOR 1641 CABLE (CATHETER TO GENERATOR)
• Type of Device: CARDIAC ABLATION PERCUTANEOUS CATHETER
• Manufacturer (Section D): ST. JUDE MEDICAL; 2375 morse ave; irvine CA 92614
• Manufacturer (Section G): ST. JUDE MEDICAL; 2375 morse ave; irvine CA 92614
• Manufacturer Contact: janna parks ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 12647982
• MDR Text Key: 276908564
• Report Number: 2030404-2021-00076
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 05414734308755
• UDI-Public: 05414734308755
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: P040014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 05/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/18/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2023
• Device Model Number: IBI-85641
• Device Catalogue Number: IBI-85641
• Device Lot Number: 7563908
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/11/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/09/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 20 YR
• Patient Sex: Male