MAUDE Adverse Event Report: ST. JUDE MEDICAL FAST-CATH¿ GUIDING INTRODUCER SEPT¿ SERIES 60 CM SHEATH, 8F; INTRODUCER, CATHETER

Model Number 406885

Device Problems Air Leak (1008); Hole In Material (1293)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/24/2017

Event Type  malfunction  

Event Description

During an atrioventricular nodal reentrant tachycardia ablation procedure, an air leak occurred.After the sheath was inserted into the patient air was aspirated.The sheath set was replaced and the procedure was completed with no adverse patient consequences.

Manufacturer Narrative

The reported event of an air leak was confirmed.The results of the investigation concluded that 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.Tearing in the seals is consistent with damage during use.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause for the reported and confirmed leak is consistent with damage during use.

• Brand Name: FAST-CATH¿ GUIDING INTRODUCER SEPT¿ SERIES 60 CM SHEATH, 8F
• 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: 6802091
• MDR Text Key: 82981830
• Report Number: 3005334138-2017-00124
• Device Sequence Number: 1
• Product Code: DYB
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K973840
• 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: 10/06/2017

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: 08/31/2019
• Device Model Number: 406885
• Device Lot Number: 5638399
• Other Device ID Number: 05414734203098
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/25/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/25/2017
• Initial Date FDA Received: 08/17/2017
• Supplement Dates Manufacturer Received: 10/04/2017
• Supplement Dates FDA Received: 10/06/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/09/2016
• 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