MAUDE Adverse Event Report: ST. JUDE MEDICA SWARTZ¿ BRAIDED TRANSSEPTAL GUIDING INTRODUCER, SL1¿, 63 CM LENGTH, 8.5F; INTRODUCER, CATHETER

Model Number 407453

Device Problem Entrapment of Device (1212)

Patient Problem No Code Available (3191)

Event Date 09/18/2018

Event Type  Injury  

Event Description

During a pulmonary vein isolation procedure, two guidewires became entangled in the patient's femoral vein.Following femoral vein puncture, the non-abbott guidewire and swartz guidewire became entangled.The guidewires were advanced several times in order to be unknotted with no resolution and a cut down was required to remove the devices.Outside of the patient, the guidewire appeared frayed.The procedure was cancelled and rescheduled following surgical removal of the devices.The patient is in stable condition.There were no performance issues with any abbott device.

Manufacturer Narrative

The guidewire had been kinked at the manufactured ¿j¿ tip and the inner core wire had been stretched and partially separated from the outer coil wire.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the reported guidewire entanglement and subsequent cut-down may have been procedure related.

• Brand Name: SWARTZ¿ BRAIDED TRANSSEPTAL GUIDING INTRODUCER, SL1¿, 63 CM LENGTH, 8.5F
• Type of Device: INTRODUCER, CATHETER
• Manufacturer (Section D): ST. JUDE MEDICA; 5050 nathan lane north; plymouth MN 55442
• Manufacturer (Section G): ST. JUDE MEDICAL; 5050 nathan lane north; plymouth MN 55442
• Manufacturer Contact: stephanie o' sullivan ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 7939286
• MDR Text Key: 122858255
• Report Number: 3005334138-2018-00353
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 05414734205771
• UDI-Public: 05414734205771
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K052644
• 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,Followup
• Report Date: 10/26/2018

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: 05/31/2021
• Device Model Number: 407453
• Device Lot Number: 6519979
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/16/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/18/2018
• Initial Date FDA Received: 10/05/2018
• Supplement Dates Manufacturer Received: 10/23/2018
• Supplement Dates FDA Received: 10/26/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/27/2018
• 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