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

Catalog Number AI-07155-KS

Device Problem Capturing Problem (2891)

Patient Problem Insufficient Information (4580)

Event Date 10/10/2023

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that while in use, the pacer wire is not conducting.At the time of this report the customer has not returned our requests for additional information.If additional information is received, the complaint file will be updated.

Event Description

It was reported that while in use, the pacer wire is not conducting.At the time of this report the customer has not returned our requests for additional information.If additional information is received, the complaint file will be updated.

Manufacturer Narrative

(b)(4).Additional information received on 01 nov 2023 states that the catheter was removed and a 2nd catheter was inserted at the same insertion site.No patient harm or injury.The patient status is reported as "fine".The reported complaint that the "pacer wire not conducting" was not confirmed based on the investigation of the returned sample.The customer returned a 5fr.Bi-polar pacing catheter with the original packaging lid-stock (inp-3, inp-6) for investigation.The sample was returned in the supplied return kit and was in a sealed bio-hazard bag (inp-1, inp-2).Upon return, the supplied 3ml luer-lock syringe was connected to the inflation lumen stopcock; no damage or abnormalities were noted to the returned syringe (inp-7).The inflation lumen stopcock was in the closed position (inp-7).The recommended volume capacity of the balloon is 0.75cc (inp-8).No condensation was noted in the inflation lumen.Under microscopic inspection, a wrinkle was noted on the balloon surface; no other damage or abnormalities were noted to the balloon (inp-9).The distal and proximal electrode appeared typical (inp-10).The distal and proximal electrode extension leads appeared typical (inp-11).No blood was noted on the interior or the exterior surfaces of the returned sample.The inflation lumen was injected with 0.75cc of air using a lab inventory control stroke syringe.The balloon inflated symmetrically (anp-1, anp-2).One side of the balloon measured approximately 4mm.The other side measured approximately 4mm.The ball oon did meet specifications per graphic of radius ratio less than or equal to 1.5.The inflation lumen was injected with 0.75cc of air using a lab inventory control stroke syringe.The balloon inflated symmetrically (anp-1, anp-2).The balloon deflated in less than 3 seconds when the syringe was removed per specification.Upon tug test, no pull away was noted.The balloon was placed in water, and air was injected into the inflation lumen again.No leak was noted.The distal electrode and distal extension lead (white wire) were connected to a multi-meter and continuity was found between the leads.The resistance measured 1.2 ohms and passed functional testing.The proximal electrode and proximal extension lead (blue wire) were connected to a multi-meter and continuity was found between the leads.The resistance measured 1.3 ohms and passed functional testing.Both distal and proximal electrodes were cross checked, and no short circuit was found.Based on a review of the device history record (dhr), the product met specification upon release.The root cause of the complaint was undetermined.No further action required at this time.Teleflex will continue to monitor and trend for complaints of this nature.

• Brand Name: PACING/PSI KIT: 5 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: kevin don bosco ; 3015 carrington mill blvd; morrisville 27560
• MDR Report Key: 18003910
• MDR Text Key: 326493241
• Report Number: 3010532612-2023-00601
• Device Sequence Number: 1
• Product Code: DRF
• UDI-Device Identifier: 10801902004533
• UDI-Public: 10801902004533
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K945229
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/10/2023

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: 03/31/2024
• Device Catalogue Number: AI-07155-KS
• Device Lot Number: 13F23A0330
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/10/2023
• Initial Date FDA Received: 10/25/2023
• Supplement Dates Manufacturer Received: 11/29/2023
• Supplement Dates FDA Received: 11/30/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/18/2023
• 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