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 05/26/2020

Event Type  Injury  

Manufacturer Narrative

The reported event of a damaged sheath was confirmed.The sheath tube had been torn and detached proximal to the distal tip.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the sheath tear and detachment is consistent with damage during use.

Event Description

During a procedure, a part of the sheath detached and had to be retrieved.When the sheath was attempted to be removed, the sheath had broken and a piece was left inside the femoral vein.A 10fr sheath and ptca balloon were used to retrieve the piece, requiring an additional access site.It was confirmed with fluoroscopy and angiography that no fragment remained in the patient.No further intervention was needed.The procedure was finished successfully with no adverse consequences to the patient.

• 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 (AFD-PLYMOUTH); 5050 nathan lane north; plymouth MN 55442
• Manufacturer Contact: stephanie o' sullivan ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 10183981
• MDR Text Key: 196082608
• Report Number: 3005334138-2020-00237
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 05414734216937
• UDI-Public: 05414734216937
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: K061015
• 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
• Report Date: 06/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/23/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2022
• Device Model Number: 406700
• Device Catalogue Number: 406700
• Device Lot Number: 6993988
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/12/2020
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/27/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/13/2019
• 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 Age: 60 YR
• Patient Weight: 70