• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

ARROW INTERNATIONAL LLC PACING/PSI KIT: 5 FR/6 FR 2-L; CATHETER, ELECTRODE RECORDING Back to Search Results
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".
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key17701577
MDR Text Key322875226
Report Number3010532612-2023-00507
Device Sequence Number1
Product Code DRF
Combination Product (y/n)N
Reporter Country CodeCA
Number of Events Reported1
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 Date01/31/2024
Device Catalogue NumberAI-07155-IK
Device Lot Number13F22J0812
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 08/23/2023
Initial Date FDA Received09/07/2023
Supplement Dates Manufacturer Received10/12/2023
Supplement Dates FDA Received10/16/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/02/2023
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
-
-