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

Catalog Number	AI-07155-KS
Medical Device Problem Code	Capturing Problem (2891)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/10/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Other remarks: n/a.Corrected data: n/a.
Event or Problem 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 or Problem 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.
Additional 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.
Additional Manufacturer Narrative
Qn#((b)(4).In section d provided the full udi # **udi related data quality updates only** other remarks: n/a.Corrected data: n/a.
Event or Problem 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.

• Brand Name: ARROW PACING/PSI KIT: 5 FR 2-L
• Common Device Name: 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: marling heaton ; 3015 carrington mill blvd; morrisville 27560
• MDR Report Key: 18003910
• Report Number: 3010532612-2023-00601
• Device Sequence Number: 12672102
• Product Code: DRF
• UDI-Device Identifier: 10801902004533
• UDI-Public: (01)10801902004533(11)230118(17)240331(10)13F23A0330(21)
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K945229
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 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
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/10/2023
• Supplement Date Received by Manufacturer: 11/29/2023; Not provided
• Initial Report FDA Received Date: 10/25/2023
• Supplement Report FDA Received Date: 11/30/2023; 08/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/18/2023
• 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
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown