MAUDE Adverse Event Report: ST. JUDE MEDICAL FAST-CATH TRIO HEMOSTASIS INTRODUCER, CATH-LOCK LOCKING HUB, 12 CM SHEATH, 12; INTRODUCER, CATHETER

Model Number 406306

Device Problem Difficult to Insert (1316)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/07/2021

Event Type  malfunction  

Event Description

During a supraventricular tachycardia ablation procedure, the non abbott catheter was difficult to insertion into the hemostasis valve following insertion into the patient which caused a delay.An attempt to insert another non-abbott catheter did not resolve the issue.The sheath set was replaced and the procedure was completed with no adverse consequences to the patient.No additional femoral vein puncture was required for replacing the sheath.

Manufacturer Narrative

Additional information: g3, h2, h3 the results of the investigation are inconclusive since the device was not returned for analysis.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.Based on the information received, the cause of the reported insertion difficulties and subsequent delay remain unknown.

• Brand Name: FAST-CATH TRIO HEMOSTASIS INTRODUCER, CATH-LOCK LOCKING HUB, 12 CM SHEATH, 12
• Type of Device: INTRODUCER, CATHETER
• Manufacturer (Section D): ST. JUDE MEDICAL; 5050 nathan lane north; plymouth MN 55442
• MDR Report Key: 11702850
• MDR Text Key: 260250362
• Report Number: 3005334138-2021-00293
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 05414734203920
• UDI-Public: 05414734203920
• 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: 04/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/21/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2022
• Device Model Number: 406306
• Device Catalogue Number: 406306
• Device Lot Number: 7046010
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1