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 Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem ST Segment Elevation (2059)

Event Date 06/21/2019

Event Type  Injury  

Manufacturer Narrative

Investigation results will be provided in the final report.

Event Description

During an atrial fibrillation procedure the ecg showed st elevation when a transseptal puncture was performed.It was believed that air entered through the sheath.After the transseptal puncture, a guide wire and catheter were introduced to place the sheath into the pulmonary vein, and a contrast bolus was delivered to perform angiography.After this sequence, st elevation occurred.The patient was treated with noradrenaline, pacing, and nitroglycerin.After approximately 30 minutes, the patient stabilized.

Manufacturer Narrative

One 8.5f swartz braided introducer sheath was received for evaluation.The sheath passed pressure and aspiration leak testing with no anomalies observed.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the reported leak remains unknown.

• 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: 8754595
• MDR Text Key: 149832053
• Report Number: 3005334138-2019-00348
• 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: 08/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/02/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2022
• Device Model Number: 407451
• Device Lot Number: 7009535
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/26/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/31/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention