MAUDE Adverse Event Report: ST. JUDE MEDICAL FAST-CATH GUIDING INTRODUCER SWARTZSR0; INTRODUCER, CATHETER

Model Number	406844
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/09/2020
Type of Reportable Event	Malfunction
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 a right-sided ablation procedure, a blood leak was observed from the hemostasis valve of the introducer.The sheath was replaced, and the procedure was completed successfully with no adverse patient consequences.
Additional Manufacturer Narrative
One 8f fast-cath introducer sheath was received for evaluation.The reported event of a leak could not be confirmed.The dilator and guidewire assembly were also received.The sheath passed pressure and aspiration leak testing with no anomalies observed.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the reported leak remains unknown.

• Brand Name: FAST-CATH GUIDING INTRODUCER SWARTZSR0
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): ST. JUDE MEDICAL; 5050 nathan lane north; plymouth MN 55442
• MDR Report Key: 10939794
• Report Number: 3005334138-2020-00574
• Device Sequence Number: 791651
• Product Code: DYB
• UDI-Device Identifier: 05414734202930
• UDI-Public: 05414734202930
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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): 12/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2022
• Device Model Number: 406844
• Device Catalogue Number: 406844
• Device Lot Number: 7157431
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/23/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/09/2020
• Supplement Date Received by Manufacturer: 12/04/2020
• Initial Report FDA Received Date: 12/03/2020
• Supplement Report FDA Received Date: 12/09/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1