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

Catalog Number	AI-06210-KS
Medical Device Problem Code	Device Sensing Problem (2917)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/19/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, "we tried to sue a temporary pacing catheter with shrouded pins/introducer kit.It was not capturing or sensing.The catheter was discarded and we got another catheter and it worked fine.We are questioning if this one was faulty".At the time of this report the customer has not returned our requests or additional information.If additional information is received, the complaint file will be updated.
Additional Manufacturer Narrative
Qn#(b)(4).Other remarks: n/a.Corrected data: n/a.
Additional Manufacturer Narrative
(b)(4).The reported complaint of pacing catheter "not capturing or sensing" is not able to be confirmed.The product was not returned for i nvestigation.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 or Problem Description
It was reported that, "we tried to sue a temporary pacing catheter with shrouded pins/introducer kit.It was not capturing or sensing.The catheter was discarded and we got another catheter and it worked fine.We are questioning if this one was faulty".At the time of this report the customer has not returned our requests or additional information.If additional information is received, the complaint file will be updated.

• Brand Name: PACING/PSI KIT: 6 FR
• 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: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 17480649
• Report Number: 3010532612-2023-00410
• Device Sequence Number: 20616677
• Product Code: DRF
• UDI-Device Identifier: 10801902198300
• UDI-Public: 10801902198300
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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
• Report Date (Section B): 07/19/2023

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: 07/31/2023
• Device Catalogue Number: AI-06210-KS
• Device Lot Number: 13F22H0516
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/19/2023
• Supplement Date Received by Manufacturer: 09/07/2023
• Initial Report FDA Received Date: 08/08/2023
• Supplement Report FDA Received Date: 09/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/08/2022
• 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