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

Model Number 405112

Device Problems Difficult to Insert (1316); Loose or Intermittent Connection (1371)

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

Event Type  malfunction  

Manufacturer Narrative

Concomitant devices: peel-away introducer kit, 8f x2.

Event Description

Related manufacturing ref: 3005334138-2021-00504, 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.

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 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
• Type of Device: INTRODUCER, CATHETER
• Manufacturer (Section D): ST. JUDE MEDICAL; 5050 nathan lane north; plymouth MN 55442
• MDR Report Key: 12300109
• MDR Text Key: 265782738
• Report Number: 3005334138-2021-00505
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 05414734204125
• UDI-Public: 05414734204125
• Combination Product (y/n): N
• PMA/PMN Number: K894431
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 09/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/10/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 09/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1