MAUDE Adverse Event Report: ST. JUDE MEDICAL BRAIDED SWARTZ¿ INTRODUCER, SL0¿. 8F, 63CM; INTRODUCER, CATHETER

Model Number G407371

Device Problem Gas/Air Leak (2946)

Patient Problems Air Embolism (1697); Paralysis (1997)

Event Date 02/18/2020

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 ref: 3005334138-2020-00069.During the procedure, while inserting two introducers, air was aspirated and entered the coronary and cerebral arteries.The air was removed from the coronary artery, but paralysis developed temporarily.The paralysis later resolved and the patient was observed.

Event Description

Additional information was received indicating the patient has been re-hospitalized due to the paralysis.

Manufacturer Narrative

One 8f swartz braided introducer sheath and dilator were received for evaluation.The sheath passed pressure and aspiration leak testing with no anomalies observed.Microscopic inspection of the hemostasis seals revealed no anomalies.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.

• Brand Name: BRAIDED SWARTZ¿ INTRODUCER, SL0¿. 8F, 63CM
• Type of Device: INTRODUCER, CATHETER
• Manufacturer (Section D): ST. JUDE MEDICAL; 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: 9750898
• MDR Text Key: 180759534
• Report Number: 3005334138-2020-00070
• Device Sequence Number: 1
• Product Code: DYB
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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,Followup
• Report Date: 04/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/25/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2022
• Device Model Number: G407371
• Device Lot Number: 7067032
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/12/2020
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/20/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/28/2019
• 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
• Treatment: SWARTZ BRAIDED INTRODUCER
• Patient Outcome(s): Required Intervention