MAUDE Adverse Event Report: ST. JUDE MEDICAL INQUIRY¿ ELECTROPHYSIOLOGY CATHETERS, DECAPOLAR, 6F; CATHETER, ELECTRODE RECORDING

Model Number	IBI-81102
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/08/2018
Type of Reportable Event	Malfunction
Event or Problem Description
During the procedure, the surface of the catheter was twisted, exposing the wire.The catheter was replaced and the procedure was completed with no adverse patient consequences.
Additional Manufacturer Narrative
One decapolar, inquiry steerable diagnostic catheter was received for evaluation.During the investigation, multiple bends were noted throughout the shaft of the catheter and electrode 5 had been displaced from its original position, exposing the conductor wire.Catheter electrode 5 broke the conductor wire spot weld and adhesive joint; displaced from its groove and moved to electrode 4.Electrode 5 left a groove mark on its original assembly position and, adhesive was noted.Dissection of the kinked sections of the catheter revealed that the flat and the activation wires were kinked at the same place of the shaft kinks.The investigation concluded that the catheter was severely damaged and the displacement of the electrode from its assembly position is consistent with the manipulation of the catheter during use.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The review determined the process was performed and completed in accordance with abbott specifications and procedures.The cause of the reported damage is consistent with damage during use.

• Brand Name: INQUIRY¿ ELECTROPHYSIOLOGY CATHETERS, DECAPOLAR, 6F
• Common Device Name: CATHETER, ELECTRODE RECORDING
• Manufacturer (Section D): ST. JUDE MEDICAL; parque industrial, zona franca coyol s.a.; edificio #44b, calle 0, avenida 2, coyol; alajuela, costa rica 1897- 4050; CS 1897-4050
• MDR Report Key: 7828600
• Report Number: 3008452825-2018-00289
• Device Sequence Number: 11371090
• Product Code: DRF
• UDI-Device Identifier: 05414734302968
• UDI-Public: 05414734302968
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K961924
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/02/2018

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: 02/28/2021
• Device Model Number: IBI-81102
• Device Catalogue Number: IBI-81102
• Device Lot Number: 6372183
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/12/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 08/09/2018
• Supplement Date Received by Manufacturer: 10/31/2018
• Initial Report FDA Received Date: 08/29/2018
• Supplement Report FDA Received Date: 11/02/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1