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 Material Perforation (2205)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/09/2018

Event Type  malfunction  

Event Description

During a procedure, during introduction of the needle into the introducer, the needle perforated the introducer.It was noted there was a kink where the perforation occurred.The introducer and needle were replaced to continue with no adverse patient consequences.

Manufacturer Narrative

The sheath and dilator had been perforated proximal to the distal tip.A needle/stylet assembly from current inventory was inserted and advanced through the dilator/sheath assembly.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the perforation is consistent with the failure to use a stylet/similar component during needle insertion through the dilator.The instruction fro use (ifu) states, ¿during insertion, always use the stylet to facilitate needle passage through the dilator/sheath assembly.Failure to use the stylet may inhibit advancement of the needle and may result in inadvertent needle puncture of the dilator/sheath assembly or skiving of material from the inner surface of the dilator.¿.

Event Description

It was noted there was a kink in the vein where the needle perforation occurred.No stylet was used.

• 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
• 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: 7832758
• MDR Text Key: 118770538
• Report Number: 3005334138-2018-00281
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 05414734205757
• UDI-Public: 05414734205757
• Combination Product (y/n): N
• Reporter Country Code: AU
• 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: 09/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2021
• Device Model Number: 407451
• Device Lot Number: 6505284
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/09/2018
• Initial Date FDA Received: 08/30/2018
• Supplement Dates Manufacturer Received: 08/30/2018
• Supplement Dates FDA Received: 09/21/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/18/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1