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	10/12/2020
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 an atrial fibrillation ablation procedure, a blood leak was noted.The sheath was replaced with the same model device to complete the procedure with no consequences to the patient.In absence of patient's written consent as required by the personal data protection national legislation.National legislation prevents the recording of such information.A written consent has not been obtained in this case; therefore, this information is not available.
Additional Manufacturer Narrative
One 8f fast-cath introducer sheath and dilator were received for evaluation.A leak was noted at the hemostasis valve during functional testing.The cap was removed from the hemostasis hub and the hemostasis seal was microscopically inspected.Tearing, resulting in a hole, was noted in the distal face of the seal.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the torn seal and subsequent leak is consistent with damage during use.The ifu states damage to the valve assembly may occur if inner catheter is withdrawn rapidly.

• 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: 10795426
• Report Number: 3005334138-2020-00559
• Device Sequence Number: 11682493
• 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): 12/04/2020

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: 08/31/2022
• Device Model Number: 406844
• Device Catalogue Number: 406844
• Device Lot Number: 7180599
• 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: 11/05/2020
• Supplement Date Received by Manufacturer: 12/04/2020
• Initial Report FDA Received Date: 11/05/2020
• Supplement Report FDA Received Date: 12/05/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1