MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. INQUIRY AFOCUSLL DIAGNOSTIC CATHETER; CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING

Model Number	IBI-87007
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/02/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation results will be provided in the final report.
Event or Problem Description
During an atrial fibrillation ablation procedure, when mapping was performed in the left atrium, it was found through fluoroscopy that the part below the loop of the catheter was kinked.The catheter was attempted to be withdrawn into the sheath without the straightener, but was not successful.The kink was attempted to be straightened with a snare, but the catheter still could not be withdrawn into the sheath.The issue was resolved after the catheter was straightened, rotated and manipulated inside of the patient.The catheter was then withdrawn into the sheath and removed from the patient.Upon inspection the catheter was found to be kinked but no other damage was noted.The procedure was completed by using another catheter and there were no adverse consequences to the patient.
Additional Manufacturer Narrative
One duodecapolar, double loop, inquiry afocusii diagnostic catheter was received for evaluation.A kink in the catheter shaft was noted 0.6¿ proximal to the sprial loop/shaft transition.No other visual anomalies were noted.The kink in the catheter shaft is consistent with the reported removal difficulty.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the bend is consistent with damage during use.

• Brand Name: INQUIRY AFOCUSLL DIAGNOSTIC CATHETER
• Common Device Name: CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.; 2375 morse ave; irvine CA 92614
• MDR Report Key: 9947756
• Report Number: 2030404-2020-00024
• Device Sequence Number: 3375118
• Product Code: DRF
• UDI-Device Identifier: 05414734309912
• UDI-Public: 05414734309912
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K101623
• 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): 05/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 10/31/2021
• Device Model Number: IBI-87007
• Device Catalogue Number: IBI-87007
• Device Lot Number: 6734821
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/22/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/02/2020
• Supplement Date Received by Manufacturer: 05/04/2020
• Initial Report FDA Received Date: 04/10/2020
• Supplement Report FDA Received Date: 05/04/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Weight: 64