MAUDE Adverse Event Report: ARGON MEDICAL DEVICES CATHETER INTRODUCER KIT 6F

Model Number	497792*
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/16/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Blue twisting "lock" on sterile sleeve of introducer was missing on 2 devices and failed to securely lock on a third.This introducer is used to place temporary transvenous pacemaker wires and when it does not lock securely, the likelihood of the wire moving out of place is higher.The chances of the sterile sleeve slipping to expose the catheter so that it's no longer sterile along its external length is also higher.This means that the wire cannot safely be advanced if needed.This has happened with 3 different kits - 1 for a patient whose wire was placed in er, 2 whose wires were placed in ccu.Sterile sleeve was extended and securely taped to the pacing catheter and the device was extensively secured into place with tape.Issue was discovered after placement and remained in patients until placement of permanent pacemaker at (b)(6).
Additional Manufacturer Narrative
Sample is unavailable for evaluation.Without such evident to review, the complaint cannot be confirmed.If additional information is provided in the future, a follow-up report will be submitted.

• Brand Name: CATHETER INTRODUCER KIT 6F
• Common Device Name: CATHETER INTRODUCER KIT 6F
• Manufacturer (Section D): ARGON MEDICAL DEVICES; 1445 flat creek rd; athens TX 75751
• Manufacturer Contact: elnaz rahman ; 1445 flat creek rd; athens, TX 75751 ; 9036759321
• MDR Report Key: 13889387
• Report Number: 0001625425-2022-00969
• Device Sequence Number: 12153340
• Product Code: DRE
• UDI-Device Identifier: 00886333214976
• UDI-Public: 00886333214976
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K780126
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 03/24/2022

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: 04/12/2026
• Device Model Number: 497792*
• Device Catalogue Number: 497792*
• Device Lot Number: 11361218
• Was Device Available for Evaluation?: No
• 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: 03/18/2022
• Initial Report FDA Received Date: 03/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown