MAUDE Adverse Event Report: ST. JUDE MEDICAL FAST-CATH TRANSSEPTAL GUIDING INTRODUCER SWARTZ SL TRANSSEPTAL SERIES, SL1 8.; INTRODUCER, CATHETER

Model Number 406849

Device Problem Gas/Air Leak (2946)

Patient Problems Stroke/CVA (1770); Embolism/Embolus (4438); Heart Block (4444)

Event Date 06/29/2021

Event Type  Injury  

Event Description

Related manufacturing ref: 3005334138-2021-00455.During a cryo-ablation procedure for paroxysmal atrial fibrillation, an air embolism and cerebrovascular accident occurred.Following transseptal puncture to the left atrium, the needle was pulled back and the guidewire was inserted into the sl1 sheath.An angiography of the pulmonary veins was performed, and the guidewire was removed from the sheath.Air was detected in the left atrium and at the same time, air was aspirated from the sl1 sheath.Another sl1 sheath was used which also aspirated air.The patient developed neurological deficits and third-degree atrioventricular (av) block, requiring reanimation, intubation and a temporary pacemaker to stabilize the patient.A ct scan revealed a cerebral infarction due to an air embolism.

Manufacturer Narrative

The results of the investigation are inconclusive since the device was not returned for analysis.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.Based on the information received, the cause of the reported an air embolism and cerebrovascular accident remain unknown.

• Brand Name: FAST-CATH TRANSSEPTAL GUIDING INTRODUCER SWARTZ SL TRANSSEPTAL SERIES, SL1 8.
• Type of Device: INTRODUCER, CATHETER
• Manufacturer (Section D): ST. JUDE MEDICAL; 5050 nathan lane north; plymouth MN 55442
• MDR Report Key: 12160159
• MDR Text Key: 261286655
• Report Number: 3005334138-2021-00454
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 05414734203388
• UDI-Public: 05414734203388
• Combination Product (y/n): N
• PMA/PMN Number: K061015
• 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: 08/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/13/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 12/31/2023
• Device Model Number: 406849
• Device Catalogue Number: 406849
• Device Lot Number: 7792122
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: FAST-CATH GUIDING INTRODUCER SWARTZ; FAST-CATH GUIDING INTRODUCER SWARTZ