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 Insufficient Information (4580)

Event Date 06/30/2023

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Other remarks: n/a.Corrected data: n/a.

Event Description

It was reported that a "temporary venous pacemaker inserted into right ij.Upon successful insertion of right ij sheath and tvp the adapter (tuohy burst) and catheter contamination shield not staying together and coming lose.When rn attempted to withdraw blood from right ij sheath sidearm air being pulled back instead of blood likely due to non-secure connection between sheath and contamination shield.There is a small yellow plastic piece inside adapter (meant to create air tight seal) that is likely coming loose allowing for air to enter line.Unable to infuse fluid through sidearm and keep patent as per policy.As a result sheath and tvp removed and new line inserted using alternate temporary pacing catheter and sheath on unit".At the time of this report, the customer has not returned our requests for additional information.If further information is received, the complaint file will be updated.

Manufacturer Narrative

(b)(4).The reported complaint of tuohy-borst damaged/defective is not able to be confirmed.The product was not returned for investigation.The specific lot number was not reported, but a device history record (dhr) review was conducted for the lot numbers shipped to this account with no relevant findings.All devices passed manufacturing specifications prior to 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.

Event Description

It was reported that a "temporary venous pacemaker inserted into right ij.Upon successful insertion of right ij sheath and tvp the adapter (tuohy burst) and catheter contamination shield not staying together and coming lose.When rn attempted to withdraw blood from right ij sheath sidearm air being pulled back instead of blood likely due to non-secure connection between sheath and contamination shield.There is a small yellow plastic piece inside adapter (meant to create air tight seal) that is likely coming loose allowing for air to enter line.Unable to infuse fluid through sidearm and keep patent as per policy.As a result sheath and tvp removed and new line inserted using alternate temporary pacing catheter and sheath on unit".At the time of this report, the customer has not returned our requests for additional information.If further information is received, the complaint file will be updated.

• 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: 17391033
• MDR Text Key: 319846715
• Report Number: 3010532612-2023-00415
• 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: 07/06/2023

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 Catalogue Number: AI-07155-IK
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/06/2023
• Initial Date FDA Received: 07/25/2023
• Supplement Dates Manufacturer Received: 08/25/2023
• Supplement Dates FDA Received: 08/28/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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