MAUDE Adverse Event Report: ST. JUDE MEDICAL SWARTZ¿ BRAIDED TRANSSEPTAL INTRODUCER, SL0¿, 8.5 F; TRANSSEPTAL CATHETER INTRODUCER

Model Number G407376

Device Problem Retraction Problem (1536)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/07/2018

Event Type  Injury  

Event Description

During the procedure, the guidewire could not be removed from the patient.When the guidewire was removed along with the introducer, a tissue like substance was noted to be attached to the tip of the introducer.The introducer was replaced and the procedure was completed with no adverse consequences to the patient.

Manufacturer Narrative

One 8.5f swartz braided introducer, dilator and guidewire were received for evaluation.The guidewire was returned fully inserted through the dilator and a tissue-like substance was visible at the dilator distal tip.The dilator distal tip had been split and scratched.The guidewire had multiple bends and the guidewire coating had been scratched.The guidewire outside diameter measurements met specifications.However, the dilator distal tip inside diameter measurement was inconclusive due to tip damage.After removal of the tissue-like substance, no resistance or other functional anomalies were noted during guidewire insertion through the dilator.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the guidewire withdrawal difficulties is consistent with the tissue-like substance found on the guidewire.The cause of the dilator tip damage and guidewire damage is consistent with damage during use.The cause of the tissue-like substance attached to the tip of the device remains unknown.

• Brand Name: SWARTZ¿ BRAIDED TRANSSEPTAL INTRODUCER, SL0¿, 8.5 F
• Type of Device: TRANSSEPTAL CATHETER INTRODUCER
• 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: 8159353
• MDR Text Key: 130167162
• Report Number: 3005334138-2018-00490
• 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: 01/14/2019

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 Expiration Date: 07/31/2021
• Device Model Number: G407376
• Device Lot Number: 6571631
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/26/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/07/2018
• Initial Date FDA Received: 12/13/2018
• Supplement Dates Manufacturer Received: 01/14/2019
• Supplement Dates FDA Received: 01/14/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/02/2018
• 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
• Patient Outcome(s): Life Threatening
• Patient Weight: 39