MAUDE Adverse Event Report: ST. JUDE MEDICAL FAST-CATH HEMOSTASIS INTRODUCER; INTRODUCER, CATHETER

Model Number	406107
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/13/2020
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 preoperative period of a permanent pacemaker implantation procedure, the sideport of the device detached, which resulted in an interruption of vital medication infusion.The procedure was completed by removing the device and implanting the permanent pacemaker.The patient was stable.
Additional Manufacturer Narrative
Two images and a video were submitted for evaluation.The extension tubing had detached from the sideport of the hemostasis body due to an insufficient amount of solvent on the extension tubing.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.Visual inspection was based solely upon a review of the photographs and video provided.The device was not returned.As a result of this finding, abbott is performing further investigation.
Additional Manufacturer Narrative
One 7f fast-cath introducer sheath was received for evaluation.The results of investigation revealed the extension tubing had detached from the sideport of the hemostasis body due to an insufficient amount of solvent on the extension tubing.

• Brand Name: FAST-CATH HEMOSTASIS INTRODUCER
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): ST. JUDE MEDICAL; 5050 nathan lane north; plymouth MN 55442
• MDR Report Key: 10337971
• Report Number: 3005334138-2020-00319
• Device Sequence Number: 17015364
• Product Code: DYB
• UDI-Device Identifier: 05414734013819
• UDI-Public: 05414734013819
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K914090
• 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): 11/03/2021

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: 04/30/2021
• Device Model Number: 406107
• Device Catalogue Number: 406107
• Device Lot Number: 6457688
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/01/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/06/2020
• Supplement Date Received by Manufacturer: 11/19/2020; 11/02/2021
• Initial Report FDA Received Date: 07/29/2020
• Supplement Report FDA Received Date: 11/21/2020; 11/03/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1