MAUDE Adverse Event Report: ST. JUDE MEDICAL SWARTZ BRAIDED TRANSSEPTAL GUIDING INTRODUCER, SL0, 63 CM LENGTH, 8.5 F; INTRODUCER, CATHETER

Model Number 407451

Device Problem Entrapment of Device (1212)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/11/2021

Event Type  Injury  

Event Description

During an atrial fibrillation ablation procedure, when mounting the guidewire into the introducer to the right atria, the guidewire became lodged in the tricuspid valve.After approximately 30 minutes of trying to retrieve the wire unsuccessfully via fluoroscopy and echocardiogram, an agilis sheath was used to retrieve the guidewire.The guidewire appeared to have a curve but was still flexible and had a small fragment of myocardium on it.The procedure continued with no consequences to the patient.An echo was performed on (b)(6) 2021 which confirmed there was no residual damage done to the valve.

Manufacturer Narrative

One 8.5f swartz braided introducer guidewire was received for evaluation.An unknown torque device was also returned.Visual inspection revealed that a yellowish foreign material (fm) was attached to the guidewire surface.Additional testing revealed the returned fm appeared to match biological material and polytetrafluoroethylene (ptfe).It was noted that the ptfe material is consistent with the guidewire manufactured coating.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.

• Brand Name: SWARTZ BRAIDED TRANSSEPTAL GUIDING INTRODUCER, SL0, 63 CM LENGTH, 8.5 F
• Type of Device: INTRODUCER, CATHETER
• Manufacturer (Section D): ST. JUDE MEDICAL; 5050 nathan lane north; plymouth MN 55442
• MDR Report Key: 11633169
• MDR Text Key: 244375413
• Report Number: 3005334138-2021-00225
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 05414734205757
• UDI-Public: 05414734205757
• Combination Product (y/n): N
• PMA/PMN Number: K052644
• 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: 07/23/2021

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
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2023
• Device Model Number: 407451
• Device Catalogue Number: 407451
• Device Lot Number: 7741215
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/03/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/11/2021
• Initial Date FDA Received: 04/08/2021
• Supplement Dates Manufacturer Received: 07/22/2021
• Supplement Dates FDA Received: 07/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other