MAUDE Adverse Event Report: ST. JUDE MEDICAL PEEL-AWAY INTRODUCER 14 CM SHEATH INTRODUCER KIT, 8F; INTRODUCER, CATHETER

Model Number	405112
Medical Device Problem Codes	Difficult to Insert (1316); Loose or Intermittent Connection (1371)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Concomitant devices: peel-away introducer kit, 8f x2.
Event or Problem Description
Related manufacturing ref: 3005334138-2021-00505, 3005334138-2021-00506.During a pacemaker implant procedure, two dilators would not fit into the sheaths which caused a delay in the procedure.A third device was obtained and tested outside the patient and the same issue occurred.A fourth device was used to complete the procedure with no adverse consequences to the patient.
Additional Manufacturer Narrative
The results of the investigation are inconclusive since the device was not returned for analysis.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.Based on the information received, the cause of the loose or intermittent connection remains unknown.
Event or Problem Description
During a pacemaker implant procedure, two dilators would not click or stay on the sheath which caused a delay in the procedure.A third device was obtained and tested outside the patient and the same issue occurred.A fourth device was used to complete the procedure with no adverse consequences to the patient.

• Brand Name: PEEL-AWAY INTRODUCER 14 CM SHEATH INTRODUCER KIT, 8F
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): ST. JUDE MEDICAL; 5050 nathan lane north; plymouth MN 55442
• MDR Report Key: 12300104
• Report Number: 3005334138-2021-00504
• Device Sequence Number: 4002864
• Product Code: DYB
• UDI-Device Identifier: 05414734204125
• UDI-Public: 05414734204125
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K894431
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/27/2021

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2023
• Device Model Number: 405112
• Device Catalogue Number: 405112
• Device Lot Number: 7681590
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/20/2021
• Supplement Date Received by Manufacturer: 09/27/2021
• Initial Report FDA Received Date: 08/10/2021
• Supplement Report FDA Received Date: 09/27/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1