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

Model Number	407847
Medical Device Problem Codes	Difficult to Insert (1316); Expiration Date Error (2528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/29/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
An expired device was used during the procedure.Difficulty was noted when advancing the device and another device was used to complete the procedure with no consequences to the patient.
Event or Problem Description
Additional information received confirmed the event date is unknown, therefore an event of an expired did not occur and should not have been submitted.
Additional Manufacturer Narrative
One 7f ultimum introducer sheath and dilator were received for evaluation.Visual inspection revealed the sheath distal tip had been bent and flared.The dilator was inserted into the sheath and a small gap was noted at the dilator/sheath transition, consistent with the damage to the distal tip.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the sheath tip damage is consistent with damage during use.The cause of the insertion difficulty remains unknown.

• 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: 11613684
• Report Number: 3005334138-2021-00233
• Device Sequence Number: 3159879
• Product Code: DYB
• UDI-Device Identifier: 05414734008969
• UDI-Public: 05414734008969
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/06/2021

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: 04/30/2020
• Device Model Number: 407847
• Device Catalogue Number: 407847
• Device Lot Number: 6001751
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/26/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/30/2021
• Supplement Date Received by Manufacturer: 04/07/2021; 05/05/2021
• Initial Report FDA Received Date: 04/05/2021
• Supplement Report FDA Received Date: 05/03/2021; 05/06/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1