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
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	05/26/2020
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): ST. JUDE MEDICAL; 5050 nathan lane north; plymouth MN 55442
• MDR Report Key: 10183981
• Report Number: 3005334138-2020-00237
• Device Sequence Number: 16370957
• Product Code: DYB
• UDI-Device Identifier: 05414734216937
• UDI-Public: 05414734216937
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K061015
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: 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
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/27/2020
• Initial Report FDA Received Date: 06/23/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 60 YR
• Patient Weight: 70