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

Catalog Number	AI-07155-KS
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/07/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The report states, "blood return from temp wire area within the swandom and blood within the sheath.I followed up with cc team and mentioned patient was shipped to bi boston for further ep testing with temp wire in place.I was told dr did see patient over the weekend, bleeding was maintained.Temp wire indication- bradycardia, syncope".
Additional Manufacturer Narrative
(b)(4).N/a.Other remarks: n/a.Corrected data: n/a.
Additional Manufacturer Narrative
(b)(4).The reported complaint of sheath leaked was not able to be confirmed as 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 was undetermined.No further action required at this time.Teleflex will continue to monitor and trend on complaints of this nature.Other remarks: n/a.Corrected data: n/a.
Event or Problem Description
The report states, "blood return from temp wire area within the swandom and blood within the sheath.I followed up with cc team and mentioned patient was shipped to bi boston for further ep testing with temp wire in place.I was told dr did see patient over the weekend, bleeding was maintained.Temp wire indication- bradycardia, syncope".
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
The report states, "blood return from temp wire area within the swandom and blood within the sheath.I followed up with cc team and mentioned patient was shipped to bi boston for further ep testing with temp wire in place.I was told dr did see patient over the weekend, bleeding was maintained.Temp wire indication- bradycardia, syncope".

• Brand Name: ARROW PACING/PSI KIT: 5 FR 2-L
• Common Device Name: CATHETER, ELECTRODE RECORDING
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• Manufacturer (Section G): ARROW INTERNATIONAL DE MEXICO S.A. DE C.V.; ave. washington 3701; colonia panamericana, chihuahua; chihuahua 31200 ; MX 31200
• Manufacturer Contact: marling heaton ; 3015 carrington mill blvd; morrisville 27560
• MDR Report Key: 18133665
• Report Number: 9680794-2023-00925
• Device Sequence Number: 7790597
• Product Code: DRF
• UDI-Device Identifier: 10801902004533
• UDI-Public: (01)10801902004533(11)230123(17)240331(10)13F23A0501(21)
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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): 11/07/2023

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: 13F23A0501
• 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: 11/07/2023
• Supplement Date Received by Manufacturer: 12/27/2023; Not provided
• Initial Report FDA Received Date: 11/14/2023
• Supplement Report FDA Received Date: 01/02/2024; 08/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/23/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: N/A.; N/A.; N/A.
• Patient Sex: Unknown