MAUDE Adverse Event Report: ST. JUDE MEDICAL FAST-CATH¿ HEMOSTASIS INTRODUCER, CATH-LOCK¿ LOCKING HUB, 12 CM SHEATH, 5 F; INTRODUCER, CATHETER

Model Number 406700

Device Problem Material Separation (1562)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 12/10/2019

Event Type  Injury  

Manufacturer Narrative

The results/method and conclusion codes along with investigation results will be provided in a subsequent submission. .

Event Description

Following the procedure, the sheath detached into the patient.While applying pressure near the access site for sheath removal, a portion of the sheath had detached in the leg of the patient.The sheath fragment migrated up to the right atrium where a snare was used to successfully retrieve the fragment.The patient is in stable condition.

Manufacturer Narrative

The results of the investigation are inconclusive since the device was not returned for analysis.Additionally, no lot number was provided so a review of the device history record (dhr) was not possible.Based on the information received, the cause of the reported material fragmentation could not be conclusively determined.

Event Description

Following the procedure, the sheath detached into the patient.While applying pressure near the access site for sheath removal, the sheath had detached near the hub and the shaft detached into the leg of the patient.The sheath fragment migrated up to the right atrium where a snare was used to successfully retrieve the fragment.The patient is in stable condition.

• Brand Name: FAST-CATH¿ HEMOSTASIS INTRODUCER, CATH-LOCK¿ LOCKING HUB, 12 CM SHEATH, 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: 9523722
• MDR Text Key: 175052048
• Report Number: 3005334138-2019-00987
• Device Sequence Number: 1
• Product Code: DYB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K061015
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 406700
• Device Catalogue Number: 406700
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/26/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Required Intervention
• Patient Weight: 110