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

Model Number 407831

Device Problem Component Misassembled (4004)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/22/2021

Event Type  malfunction  

Event 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 (38 units).The used devices were discarded.

Manufacturer Narrative

Fsca number: 3005334138-11/22/21-001-r.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
• Type of Device: 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: 12868865
• MDR Text Key: 282892153
• Report Number: 3005334138-2021-00752
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 05414734008808
• UDI-Public: 05414734008808
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K031137
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 11/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/24/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 11/12/2021
• Date Device Manufactured: 11/20/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: SEE H10
• Patient Sequence Number: 1
• Treatment: ULTIMUM HEMOSTASIS INTRODUCER X39