MAUDE Adverse Event Report: ST. JUDE MEDICAL ULTIMUM HEMOSTASIS INTRODUCER; INTRODUCER, CATHETER

Model Number	407844
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/29/2021
Type of Reportable Event	Malfunction
Event or Problem Description
During the procedure, the introducer cracked while being introduced into the patient.The device was replaced with a non-abbott device and the procedure was completed with no adverse patient consequences.
Additional Manufacturer Narrative
One 6f ultimum introducer sheath was received for evaluation.The sheath tubing had been partially torn; the torn sheath tubing remained attached.The dilator was not returned.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the sheath tear is consistent with damage during use.

• Brand Name: ULTIMUM HEMOSTASIS INTRODUCER
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): ST. JUDE MEDICAL; 5050 nathan lane north; plymouth MN 55442
• MDR Report Key: 11392197
• Report Number: 3005334138-2021-00105
• Device Sequence Number: 1164986
• Product Code: DYB
• UDI-Device Identifier: 05414734008921
• UDI-Public: 05414734008921
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K031137
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/05/2021

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: 03/31/2023
• Device Model Number: 407844
• Device Catalogue Number: 407844
• Device Lot Number: 7477287
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/25/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/05/2021
• Supplement Date Received by Manufacturer: 03/02/2021
• Initial Report FDA Received Date: 03/01/2021
• Supplement Report FDA Received Date: 03/05/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1