MAUDE Adverse Event Report: ST. JUDE MEDICAL, COSTA RICA LTDA INQUIRY¿ STEERABLE DIAGNOSTIC CATHETER; CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING

Model Number	IBI-81107
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/20/2019
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 an ablation procedure, foreign material was observed on the catheter.Following insertion within the patient the catheter was withdrawn and a foreign material was noted on the tip.The catheter was replaced to continue the procedure.There were no adverse patient consequences.
Additional Manufacturer Narrative
One decapolar, inquiry steerable diagnostic catheter was received for evaluation.Microscopic inspection of the distal tip revealed a foreign material on the distal electrode.Further investigation revealed the foreign substance was dried biological material.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the reported foreign material was not conclusively determined.

• Brand Name: INQUIRY¿ STEERABLE DIAGNOSTIC CATHETER
• Common Device Name: CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
• Manufacturer (Section D): ST. JUDE MEDICAL, COSTA RICA LTDA; 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: 8841724
• Report Number: 3008452825-2019-00375
• Device Sequence Number: 16967617
• Product Code: DRF
• UDI-Device Identifier: 05414734303002
• UDI-Public: 05414734303002
• Combination Product (Y/N): N
• Initial Reporter Country: DA
• 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): 09/05/2019

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: 11/30/2021
• Device Model Number: IBI-81107
• Device Catalogue Number: IBI-81107
• Device Lot Number: 6778801
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/26/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/12/2019
• Supplement Date Received by Manufacturer: 08/29/2019
• Initial Report FDA Received Date: 07/30/2019
• Supplement Report FDA Received Date: 09/05/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1