MAUDE Adverse Event Report: ST. JUDE MEDICAL FAST-CATH¿ GUIDING INTRODUCER SWARTZ¿ SR SERIES, SR0¿ 8.5F; INTRODUCER, CATHETER

Model Number	406853
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	10/07/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The results/method and conclusion codes along with investigation results will be provided in a subsequent submission.
Event or Problem Description
During an electrophysiology (ep) procedure a device detachment occurred.An sr0 sheath was used for an ep procedure on (b)(6) 2019 using transseptal approach.At the end of the procedure the sheath was removed whilst placing a z-suture and the sheath was inadvertently sheared leaving approximately 24 cm in the inferior vena cava (ivc).On (b)(6) 2019 during an ablation procedure the device fragment was removed from the upper ivc using a snare.There were no adverse patient consequences.
Additional Manufacturer Narrative
One 8.5f fast-cath introducer sheath was received for evaluation.The sheath tube had been torn and separated.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the torn sheath is consistent with damage during use.

• Brand Name: FAST-CATH¿ GUIDING INTRODUCER SWARTZ¿ SR SERIES, SR0¿ 8.5F
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): ST. JUDE MEDICAL; 5050 nathan lane north; plymouth MN 55442
• MDR Report Key: 9240540
• Report Number: 3005334138-2019-00583
• Device Sequence Number: 16617403
• Product Code: DYB
• UDI-Device Identifier: 05414734202985
• UDI-Public: 05414734202985
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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): 12/04/2019

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: 12/31/2021
• Device Model Number: 406853
• Device Lot Number: 6819533
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/04/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/07/2019
• Supplement Date Received by Manufacturer: 11/13/2019
• Initial Report FDA Received Date: 10/25/2019
• Supplement Report FDA Received Date: 12/04/2019
• 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: 19 YR
• Patient Weight: 55