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 Problems Entrapment of Device (1212); Difficult to Remove (1528)

Patient Problems Unspecified Infection (1930); Tissue Damage (2104)

Event Date 01/29/2019

Event Type  Injury  

Event Description

During a procedure, the wire was tangled and stuck in the puncture needle.Following removal, tissue was noted on the end of the device.There was no lesion noted, however the patient had phlebitis due to the ablation procedure or the wire issue.The procedure was able to be completed.

Event Description

No additional treatment was administered, as the patient was under anticoagulant due to the atrial fibrillation and the patient was stabilized.

Manufacturer Narrative

One guidewire was received for evaluation.The manufactured ¿j¿ tip of the guidewire had been knotted, consistent with the guidewire becoming stuck.A blood-like substance was noted at the knotted ¿j¿ tip of the guidewire.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the knotted guidewire and tissue / blood-like substance is consistent with damage during use.Further information regarding the event were requested but not received.

• 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: 8375043
• MDR Text Key: 137295551
• Report Number: 3005334138-2019-00110
• 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,Followup
• Report Date: 06/19/2019

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: 10/31/2021
• Device Model Number: 407451
• Device Lot Number: 6724440
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/26/2019
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/25/2019
• Initial Date FDA Received: 02/27/2019
• Supplement Dates Manufacturer Received: 03/04/2019; 06/17/2019
• Supplement Dates FDA Received: 03/22/2019; 06/19/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other