MAUDE Adverse Event Report: ST. JUDE MEDICAL PEEL-AWAY INTRODUCER 14CM SHEATH INTRODUCER KIT, 6F; INTRODUCER, CATHETER

Model Number	405104
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/26/2020
Type of Reportable Event	Malfunction
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 the procedure, a blood leak occurred.After placing the introducer and dilator, blood began to leak from the introducer hub.The introducer was replaced and the procedure was completed with no adverse consequences to the patient.No additional puncture was required for replacing the introducer.
Additional Manufacturer Narrative
One 6f peel-away introducer sheath was received for evaluation.The sheath tubing had been split at the medial section along the score line, consistent with the reported event.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the sheath tubing split is consistent with damage during use.

• Brand Name: PEEL-AWAY INTRODUCER 14CM SHEATH INTRODUCER KIT, 6F
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): ST. JUDE MEDICAL; 5050 nathan lane north; plymouth MN 55442
• MDR Report Key: 10882152
• Report Number: 3005334138-2020-00537
• Device Sequence Number: 3285219
• Product Code: DYB
• UDI-Device Identifier: 05414734204088
• UDI-Public: 05414734204088
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K894431
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 02/15/2021

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: 09/30/2022
• Device Model Number: 405104
• Device Catalogue Number: 405104
• Device Lot Number: 7253237
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/01/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/27/2020
• Supplement Date Received by Manufacturer: 12/18/2020; 12/18/2020; 12/18/2020
• Initial Report FDA Received Date: 11/22/2020
• Supplement Report FDA Received Date: 12/20/2020; 12/28/2020; 02/15/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1