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

Model Number	IBI-81107
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Codes	Stroke/CVA (1770); Foreign Body Embolism (4439)
Date of Event	03/02/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
Related mfr numbers: 2182269-2021-00023; 3005334138-2021-00146; 3008452825-2021-00131; 3005334138-2021-00147.Following the atrial fibrillation procedure, the patient experienced a stroke.The procedure was completed with no issues.One hour after waking up, the patient experienced hemiplegia, and a computerized tomography scan showed a cerebral thrombus.A thrombosuction was performed, and a small piece of plastic was aspirated with the thrombus.The plastic piece was believed to have originated from the agilis introducer.The patient had a small brain bleed following the thrombosuction and was not yet stable.They exhibited disordered vision and speech three days following the event.As of (b)(6) 2021, the patient was stable, but still had some neurological sequelae including temporo-spatial disorientation and disinhibition.
Additional Manufacturer Narrative
An event of a stroke was reported.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 incident could not be conclusively determined.
Event or Problem Description
The foreign material was returned and determined to be biological tissue.

• Brand Name: INQUIRY STEERABLE DIAGNOSTIC CATHETER
• Common Device Name: CATHETER, ELECTRODE RECORDING, OR PROBE, 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: 11684742
• Report Number: 3008452825-2021-00130
• Device Sequence Number: 3015419
• Product Code: DRF
• UDI-Device Identifier: 05414734303002
• UDI-Public: 05414734303002
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K961924
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/17/2021

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: 11/30/2023
• Device Model Number: IBI-81107
• Device Catalogue Number: IBI-81107
• Device Lot Number: 7768555
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/02/2021
• Supplement Date Received by Manufacturer: 04/21/2021
• Initial Report FDA Received Date: 04/19/2021
• Supplement Report FDA Received Date: 05/17/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ADVISOR HD 16 ELECTRODE DF; AGILIS NXT 8.5F LARGE CURL; SWARTZ BRAIDED INTRODUCER; TACTICATH SE CATHETER; ADVISOR HD 16 ELECTRODE DF; AGILIS NXT 8.5F LARGE CURL; SWARTZ BRAIDED INTRODUCER; TACTICATH SE CATHETER
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 72 YR
• Patient Weight: 85