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
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	05/04/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The results, method and conclusion codes along with investigation results will be provided in the final report.
Event or Problem Description
During a procedure, when removing the introducer, the shaft became separated from the hub of the sheath and remained inside the patient's vein.Surgical intervention, along with fluoroscopy, was required to remove the detached portion of the sheath.The patient remained in stable condition.
Additional Manufacturer Narrative
One 12f fast-cath trio introducer sheath was received for evaluation.The sheath tubing had been detached from the sheath hub; the sheath tubing had been fractured; the proximal section was not returned.It was noted that the returned distal section of sheath tubing was torn and had multiple instrument teeth marks at the proximal end; the distal end had been flattened and kinked.Dissection of the sheath hub and sheath tubing visual inspection revealed all components of the sheath hub and sheath tubing were present and met specifications.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the sheath tubing detachment is consistent with damage during use.

• Brand Name: FAST-CATH TRIO HEMOSTASIS INTRODUCER, CATH-LOCK LOCKING HUB, 12 CM SHEATH, 12
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): ST. JUDE MEDICAL; 5050 nathan lane north; plymouth MN 55442
• MDR Report Key: 10032114
• Report Number: 3005334138-2020-00180
• Device Sequence Number: 16826509
• Product Code: DYB
• UDI-Device Identifier: 05414734203920
• UDI-Public: 05414734203920
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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,Followup
• Report Date (Section B): 08/21/2020

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: 406306
• Device Catalogue Number: 406306
• Device Lot Number: 7004218
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/28/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/05/2020
• Supplement Date Received by Manufacturer: 08/20/2020
• Initial Report FDA Received Date: 05/07/2020
• Supplement Report FDA Received Date: 08/21/2020
• 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