MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. VIEWFLEX¿ XTRA ICE CATHETER; CATHETER, ULTRASOUND, INTRAVASCULAR

Model Number D087031

Device Problem Difficult to Insert (1316)

Patient Problems Vascular Dissection (3160); Unspecified Tissue Injury (4559)

Event Date 11/17/2021

Event Type  Injury  

Event Description

During the procedure, a dissection of the left femoral vein occurred.The patient presented to the lab in atypical flutter.As the physician was advancing the ice catheter to go transseptal for atrial fibrillation ablation, resistance was encountered.Fluoroscopy was used to visualize the ice catheter and while it was following the same track as the sl1 that was place, it did not advance as expected.Ok the ice catheter withdrawn and a.035 wire was advanced normally.A venogram of the left femoral vein was performed which showed staining outside the vein.An art line was placed to monitor blood pressure.The patient's blood pressure started to drop and cardioversion was performed to get the patient into nsr and the pressure got better.An abdominal ultrasound was performed to assess for any retro peritoneal bleeding; none was seen.The blood pressure was stable and the procedure was completed without further incident.After case completion, another left femoral venogram performed and staining still present and slightly larger.The physician believes the staining outside the vein is a result of a dissection caused by the ice catheter.The patient was sent for an abdominal ct and placed in icu for observation.

Manufacturer Narrative

Additional information: d9, g3, h2, h3 one viewflex xtra ice catheter was received for evaluation.No visual anomalies were noted.The catheter met imaging specifications in the deflected and undeflected states, additionally the outer diameter of the catheter shaft met specifications.The catheter was recognized by the catheter interface module and zonare viewmate system and produced a clear image with no blurring or artifacts noted.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the reported dissection remains unknown.

Event Description

Upon review of the file, the decision was made to update the coding to vascular dissection e0515.

Manufacturer Narrative

Additional information.Correction: h6: health effect clinical code.

• Brand Name: VIEWFLEX¿ XTRA ICE CATHETER
• Type of Device: CATHETER, ULTRASOUND, INTRAVASCULAR
• 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: janna parks ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 12915488
• MDR Text Key: 281590071
• Report Number: 2030404-2021-00094
• Device Sequence Number: 1
• Product Code: OBJ
• UDI-Device Identifier: 05415067002082
• UDI-Public: 05415067002082
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K133853
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 04/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/02/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/21/2022
• Device Model Number: D087031
• Device Catalogue Number: D087031
• Device Lot Number: 8108991
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/23/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/17/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/21/2021
• 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: 81 YR
• Patient Sex: Female
• Patient Weight: 85 KG