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

Model Number G407371

Device Problem Air Leak (1008)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/25/2018

Event Type  malfunction  

Event Description

Related manufacturing ref 3005334138-2018-00177.During a pulmonary vein isolation procedure, air aspirated into the syringe of two introducers.The introducers were replaced and the procedure was completed with no adverse consequences to the patient.

Manufacturer Narrative

A leak was noted at the hemostasis valve during functional testing.The cap was removed from the hemostasis hub and the hemostasis seals were microscopically inspected.Tearing, resulting in a hole, was noted in the proximal and distal seals.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the torn seals and subsequent leak is consistent with damage during use.The ifu states, do not remove dilator or catheter rapidly.Damage to the valve may occur, potentially compromising hemostasis.

• 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: denise johnson ; 5050 nathan lane north; plymouth, MN 55442 ; 6517564470
• MDR Report Key: 7637411
• MDR Text Key: 112310223
• Report Number: 3005334138-2018-00178
• 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
• Report Date: 06/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/26/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2020
• Device Model Number: G407371
• Device Lot Number: 6277004
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/21/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/28/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/15/2018
• 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
• Treatment: BRAIDED SWARTZ¿ INTRODUCER