MAUDE Adverse Event Report: ST. JUDE MEDICAL FAST-CATH HEMOSTASIS INTRODUCER; INTRODUCER, CATHETER

Model Number	406103
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	01/30/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
During a backup procedure for the orthopedic surgery on january 17th, the fast-cath hemostasis introducer was inserted, and a non-abbott (5f swan-ganz temporary pacing catheter) was inserted.After completing the surgery, the fast-cath hemostasis introducer and non-abbott (5f swan-ganz temporary pacing catheter) were removed.On the evening of january 30th during the catheter examination under radioscopy, a portion of what appeared to be the fast-cath hemostasis introducer that had been removed was found inside the blood vessel at the entrance of the left groin vein, and it was removed smoothly using forceps.There is a scratch on the tip of the fast-cath hemostasis introducer from when it was removed with forceps.On january 17th, no physical damage to the sheath was noted and there were no issues or resistance noted during the procedure and the patient was discharged.The patient was discharged again after removal of the retained sheath still in stable condition.
Additional Manufacturer Narrative
One 6f fast-cath introducer sheath without the hub was received for evaluation.The hub was detached from the sheath tubing and was not returned for analysis.Additionally, the sheath had been scratched and twisted.The cause of the scratch and twisting in the sheath tube is consistent with damage during use.
Additional Manufacturer Narrative
Additional information: d4, g1, g3, h2, h6, h11.

• Brand Name: FAST-CATH HEMOSTASIS INTRODUCER
• Common Device Name: 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: wendy mccarty ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 18753840
• Report Number: 3005334138-2024-00062
• Device Sequence Number: 3837599
• Product Code: DYB
• UDI-Device Identifier: 05414734013772
• UDI-Public: (01)05414734013772(10)8493480(17)250430
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K914090
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/05/2024

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: 04/30/2025
• Device Model Number: 406103
• Device Catalogue Number: 406103
• Device Lot Number: 8493480
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/01/2024
• Supplement Date Received by Manufacturer: 03/27/2024; 08/05/2024
• Initial Report FDA Received Date: 02/21/2024
• Supplement Report FDA Received Date: 04/01/2024; 08/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/26/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown