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

Model Number	407831
Medical Device Problem Code	Component Misassembled (4004)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/22/2021
Type of Reportable Event	Malfunction
Event or Problem Description
During device preparation, when the sheath was flushed and the dilator was inserted into the sheath, it was noted that the sheath was longer than the dilator.The introducer was replaced, and the same issue was noted.Another introducer of a different lot was used to complete the procedure successfully with no adverse patient consequences.All boxes of lot number 7748246 to be returned ((b)(4)).The used devices were discarded.
Additional Manufacturer Narrative
Fsca number: (b)(4).The investigation showed that the returned dilator did not reach the distal end of the sheath while engaged.Further investigation revealed the sheath length did not meet manufacturing specifications, as a 12cm fast-cath hemo was processed and packaged in place of a 5cm ultimum hemo.Length measurements confirmed there was a component mix, which has been determined to be manufacturing related.

• Brand Name: ULTIMUM HEMOSTASIS INTRODUCER
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): ST. JUDE MEDICAL; 5050 nathan lane north; plymouth MN 55442
• Manufacturer (Section G): ST. JUDE MEDICAL; 5050 nathan lane north; plymouth MN 55442
• Manufacturer Contact: janna parks ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 12869046
• Report Number: 3005334138-2021-00742
• Device Sequence Number: 6119852
• Product Code: DYB
• UDI-Device Identifier: 05414734008808
• UDI-Public: 05414734008808
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 11/24/2021

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: 10/31/2023
• Device Model Number: 407831
• Device Catalogue Number: 407831
• Device Lot Number: 7748246
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/02/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/12/2021
• Initial Report FDA Received Date: 11/24/2021
• Date Device Manufactured: 11/20/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: SEE H10
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ULTIMUM HEMOSTASIS INTRODUCER X39
• Patient Sex: Unknown