MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. INQUIRY¿ OPTIMA¿ DIAGNOSTIC CATHETER; CATHETER, ELECTRODE RECORDING

Model Number IBI-81250

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Embolism (1829)

Event Date 01/29/2019

Event Type  Injury  

Event Description

Related manufacturing ref: 3005334138-2019-00094, 3005334138-2019-00095, 3005334138-2019-00096.Following an atrial fibrillation procedure, an embolic event occurred.During the procedure, the impedance had increased during ablation.The catheter was removed from the patient and no anomalies were observed on the catheter tip.The catheter was reinserted into the patient and the procedure was completed with no adverse consequences to the patient.Following the procedure, the patient experienced decreased visual acuity and difficulty speaking.Symptoms of an embolic event were observed so the patient was transferred to another hospital.During transfer, the patient became paralyzed on the left side of the body.An mri and ct scan were performed and revealed a substance within the brain, similar in intensity to brain bones.Thrombolytic agent was administered but would not dissolve the substance.Therefore, the unknown substance was not believed to be a clot.A catheter was used to try and remove the substance with no resolution.The patient still has paralysis in their left leg but is able to speak.There were no performance issues with any abbott device.

Manufacturer Narrative

One duodecapolar, spiral loop inquiry diagnostic catheter was received for evaluation.The catheter met specifications for outer diameter measurement.The device met specifications prior to leaving abbott manufacturing facilities as supported by a review of the device history record.The cause of the reported embolic event remains unknown.

• Brand Name: INQUIRY¿ OPTIMA¿ DIAGNOSTIC CATHETER
• Type of Device: CATHETER, ELECTRODE RECORDING
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.; 2375 morse ave; irvine CA 92614
• MDR Report Key: 8354262
• MDR Text Key: 136646625
• Report Number: 2030404-2019-00011
• Device Sequence Number: 1
• Product Code: DRF
• Combination Product (y/n): N
• PMA/PMN Number: K042775
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 03/11/2019

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
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2021
• Device Model Number: IBI-81250
• Device Lot Number: 6612754
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/20/2019
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/30/2019
• Initial Date FDA Received: 02/20/2019
• Supplement Dates Manufacturer Received: 03/07/2019
• Supplement Dates FDA Received: 03/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SWARTZ¿ BRAIDED TRANSSEPTAL INTRODUCER; SWARTZ¿ BRAIDED TRANSSEPTAL INTRODUCER; TACTICATH¿ CONTACT FORCE CATHETER, SENSOR ENABLED¿; SWARTZ¿ BRAIDED TRANSSEPTAL INTRODUCER; SWARTZ¿ BRAIDED TRANSSEPTAL INTRODUCER; TACTICATH¿ CONTACT FORCE CATHETER, SENSOR ENABLED¿
• Patient Outcome(s): Required Intervention
• Patient Age: 51 YR
• Patient Weight: 77