MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC INQUIRY AFOCUSII¿ (4 F DOUBLE LOOP) CATHETER 20 ELECTRODE, 7F; CATHETER, ELECTRODE RECORDING

Model Number IBI-87008

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

Patient Problem Pleural Effusion (2010)

Event Date 07/25/2018

Event Type  Injury  

Manufacturer Narrative

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 Description

Related manufacturing ref: 9680001-2018-00119, 3008452825-2018-00275.Following an atrial fibrillation ablation procedure, the patient presented with congestion, right atelectasis and a pleural effusion.One-day post procedure, the patient experienced symptomatic hypotension, secondary to a junctional rhythm.Which improved with vigorous hydration and iv atropine.The patient then experienced chest pain and a chest x-ray revealed congestion, right atelectasis and a pleural effusion.Intravenous furosemide was administered along with intensification of respiratory physiotherapy and the patient¿s symptoms improved.The patient was later discharged.

• Brand Name: INQUIRY AFOCUSII¿ (4 F DOUBLE LOOP) CATHETER 20 ELECTRODE, 7F
• Type of Device: CATHETER, ELECTRODE RECORDING
• Manufacturer (Section D): ST. JUDE MEDICAL, INC; 2375 morse ave; irvine CA 92614
• Manufacturer (Section G): ST. JUDE MEDICAL, INC.; 2375 morse ave; irvine CA 92614
• Manufacturer Contact: elizabeth boltz ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 7802411
• MDR Text Key: 117787258
• Report Number: 2030404-2018-00061
• Device Sequence Number: 1
• Product Code: DRF
• UDI-Device Identifier: 05414734309929
• UDI-Public: 05414734309929
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K042775
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/21/2018

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: 02/29/2020
• Device Model Number: IBI-87008
• Device Lot Number: 5896932
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/30/2018
• Initial Date FDA Received: 08/21/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/16/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: AGILIS NXT STEERABLE INTRODUCER; TACTICATH ABLATION CATHETER
• Patient Outcome(s): Required Intervention
• Patient Age: 56 YR