MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW CATH PKGD: WEDGE 6 FR 110 CM; CATHETER, FLOW DIRECTED

Catalog Number	AI-07126
Medical Device Problem Code	Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/06/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported "it was reported that the lumen was flushed without problem.However, when the user inserted a guidewire through the catheter, it stopped on the way and could not be advanced further.The user replaced the catheter with another one, but the same issue occurred.No injury to the patient was reported".A third catheter was inserted to continue therapy.The patient's current condition is "unknown".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.
Additional Manufacturer Narrative
Qn#(b)(4).Additional information received from the customer states that the third catheter was inserted into the same insertion site.The customer also reports the patient's current condition as "fine".Complaint verification testing could not be performed as no sample was returned for analysis.A device history record review was performed, and no relevant findings were identified.Without the device to evaluate the complaint could not be confirmed and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.If the sample becomes available at a later date a follow up report will be submitted with investigation results.
Event or Problem Description
It was reported "it was reported that the lumen was flushed without problem.However, when the user inserted a guidewire through the catheter, it stopped on the way and could not be advanced further.The user replaced the catheter with another one, but the same issue occurred.No injury to the patient was reported".A third catheter was inserted to continue therapy.The patient's current condition is "unknown".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.Associated mdr#: 3010532612-2025-00011.

• Brand Name: ARROW CATH PKGD: WEDGE 6 FR 110 CM
• Common Device Name: CATHETER, FLOW DIRECTED
• Manufacturer (Section D): ARROW INTERNATIONAL LLC; morrisville NC
• Manufacturer (Section G): ARROW INTERNATIONAL INC.; 16 elizabeth drive; chelmsford MA 01824
• Manufacturer Contact: sachin sony ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 21056835
• Report Number: 3010532612-2025-00009
• Device Sequence Number: 8068141
• Product Code: DYG
• UDI-Device Identifier: 00801902002877
• UDI-Public: (01)00801902002877(11)240412(17)250930(10)16F24D0030(21)
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K892530
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/06/2024

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 Expiration Date: 09/30/2025
• Device Catalogue Number: AI-07126
• Device Lot Number: 16F24D0030
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/06/2024
• Supplement Date Received by Manufacturer: 01/23/2025
• Initial Report FDA Received Date: 01/02/2025
• Supplement Report FDA Received Date: 02/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/12/2024
• 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