MAUDE Adverse Event Report: ST. JUDE MEDICAL FAST-CATH TRANSSEPTAL GUIDING INTRODUCER SWARTZ SL TRANSSEPTAL SERIES, SL1 8.; INTRODUCER, CATHETER

Model Number 406849

Device Problem Fracture (1260)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/04/2020

Event Type  malfunction  

Manufacturer Narrative

The results/method and conclusion codes along with investigation results will be provided in a subsequent submission.Further information was requested but not received.

Event Description

During an atrial fibrillation ablation procedure, a crack was noted on the tip of the inner sheath following insertion into the patient (and blood can leak out of the sheath).The sheath was replaced with the same model of the device in order to complete the procedure with no adverse consequences to the patient.

Manufacturer Narrative

One 8.5f fast-cath introducer sheath and dilator were received for evaluation.Visual inspection revealed the dilator distal tip had been split.Functional testing revealed a leak at the hemostasis valve.The cap was removed from the hemostasis hub and the hemostasis seal was microscopically inspected.Tearing, resulting in a hole was noted in the seal.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the torn seal 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: FAST-CATH TRANSSEPTAL GUIDING INTRODUCER SWARTZ SL TRANSSEPTAL SERIES, SL1 8.
• Type of Device: INTRODUCER, CATHETER
• Manufacturer (Section D): ST. JUDE MEDICAL; 5050 nathan lane north; plymouth MN 55442
• MDR Report Key: 11107929
• MDR Text Key: 228227318
• Report Number: 3005334138-2021-00001
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 05414734203388
• UDI-Public: 05414734203388
• Combination Product (y/n): N
• PMA/PMN Number: K061015
• 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: 01/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/04/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2023
• Device Model Number: 406849
• Device Catalogue Number: 406849
• Device Lot Number: 7512927
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/12/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1