MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC PACING/PSI KIT: 5 FR/6 FR 2-L; CATHETER, ELECTRODE RECORDING

Catalog Number AI-07155-IK

Device Problem Leak/Splash (1354)

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

Event Date 07/30/2023

Event Type  malfunction  

Event Description

The report states that the "seal on sheath is leaking, back flow of blood and fluid into sterile wire cover.Unable to infuse vasopr essors/lifesaving medication through side arm because leaking up into sterile protector.Unable to remove pacer wire".Further information received states that the issue was resolved by using peripheral iv's instead.A new catheter was not inserted.The pacing cat heter was removed normally when no longer needed, it was not difficult to remove.No patient harm or injury.The patient status is reported as "stable".

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

(b)(4).The reported complaint that the "seal on sheath is leaking, back flow of blood and fluid into sterile wire cover" is not able to be confirmed.The product was not returned for investigation.Based on a review of the device history record (dhr), the product met specification upon release.The root cause of the complaint is undetermined.No further action required at this time.The reported complaint will be monitored for any developing trends.Other remarks: n/a.Corrected data: n/a.

Event Description

The report states that the "seal on sheath is leaking, back flow of blood and fluid into sterile wire cover.Unable to infuse vasopr essors/lifesaving medication through side arm because leaking up into sterile protector.Unable to remove pacer wire".Further information received states that the issue was resolved by using peripheral iv's instead.A new catheter was not inserted.The pacing cat heter was removed normally when no longer needed, it was not difficult to remove.No patient harm or injury.The patient status is reported as "stable".

• Brand Name: PACING/PSI KIT: 5 FR/6 FR 2-L
• Type of Device: CATHETER, ELECTRODE RECORDING
• Manufacturer (Section D): ARROW INTERNATIONAL LLC; morrisville NC
• Manufacturer (Section G): ARROW INTERNATIONAL INC.; 16 elizabeth drive; chelmsford MA 01824
• Manufacturer Contact: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 17701577
• MDR Text Key: 322875226
• Report Number: 3010532612-2023-00507
• Device Sequence Number: 1
• Product Code: DRF
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/23/2023

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
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2024
• Device Catalogue Number: AI-07155-IK
• Device Lot Number: 13F22J0812
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/23/2023
• Initial Date FDA Received: 09/07/2023
• Supplement Dates Manufacturer Received: 10/12/2023
• Supplement Dates FDA Received: 10/16/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/02/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1