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 Gas/Air Leak (2946)

Patient Problem ST Segment Elevation (2059)

Event Date 06/20/2019

Event Type  Injury  

Manufacturer Narrative

The results/method and conclusion codes along with investigation results will be provided in a subsequent submission.

Event Description

Related manufacturing reference: 3005334138-2019-00356.During a redo atrial fibrillation ablation procedure, st segment elevation occurred.Following transseptal puncture, guided by x-ray and echocardiography imaging, contrast injection revealed the sheath in the transverse pericardial space instead of the left atrium.Blood pressure and oxygen saturation levels remained stable when this was observed but the electrocardiogram showed st segment elevation which resolved on its own.The procedure was continued and a second transseptal puncture was performed.While confirming the sheath was in the left atrium via contrast injection, st segment elevation recurred.The patient then became hypotensive, oxygen saturation levels declined and the patient went into atrioventricular node block along with a ventricular tachycardia episode.The procedure was stopped and the st elevation resolved without intervention and adrenaline and oxygen was administered to recover the heart.Coronary and cerebral angiography confirmed there was no air embolism following the symptoms but transesophageal images indicated small air bubbles in the left cavities before st elevation had occurred.The patient left the or in stable condition.

Manufacturer Narrative

One 8.5f swartz braided introducer sheath was received for evaluation.No visual anomalies were noted on the sheath.The sheath passed pressure and aspiration leak testing with no anomalies observed.Review of the device history record was not possible as the lot number is unknown.The cause of the reported st segment elevation 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: 8771412
• MDR Text Key: 150401919
• Report Number: 3005334138-2019-00355
• Device Sequence Number: 1
• Product Code: DYB
• 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: 08/13/2019

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 Model Number: 407451
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/31/2019
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/20/2019
• Initial Date FDA Received: 07/09/2019
• Supplement Dates Manufacturer Received: 08/06/2019
• Supplement Dates FDA Received: 08/13/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention