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

Model Number IBI-81595

Device Problem Detachment Of Device Component (1104)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 01/10/2018

Event Type  Injury  

Manufacturer Narrative

An event of an inability to remove the catheter from inside the body was reported.The results of the investigation are inconclusive since the device was not returned for analysis; however, five images were submitted for evaluation.The images appear to show that the catheter had been fractured just proximal to the spiral loop.Visual inspection was based solely upon a review of the photographs received.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the fracture and the removal difficulty remains unknown.

Event Description

During an atrial fibrillation ablation procedure the diagnostic catheter became stuck in the patient.Following the procedure the catheter became stuck in the chiari network and could not be removed via the same route of introduction.The catheter was surgically removed through a small incision at the point of insertion.Fluoroscopy confirmed successful removal of the stuck component.The patient was stable.

• Brand Name: INQUIRY¿ AFOCUSLL¿ DIAGNOSTIC CATHETER
• Type of Device: ELECTRODE RECORDING CATHETER
• 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: denise johnson ; 5050 nathan lane north; plymouth, MN 55442 ; 6517564470
• MDR Report Key: 7215118
• MDR Text Key: 98085270
• Report Number: 2030404-2018-00003
• Device Sequence Number: 1
• Product Code: DRF
• 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: 01/24/2018

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: 11/30/2019
• Device Model Number: IBI-81595
• Device Lot Number: 5775364
• Other Device ID Number: 05414734305013
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/10/2018
• Initial Date FDA Received: 01/24/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/20/2016
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 67 YR