MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. PSI KIT: 9 FR X 4-1/8" (10 CM); INTRODUCER, CATHETER

Catalog Number	ASK-09903-LC2
Medical Device Problem Codes	Deformation Due to Compressive Stress (2889); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/14/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
Customer reported the inability to advance the spring wire guide.Upon removal, the wire appeared bent/misshaped.The customer wasn't sure if this was a product defect.The reported defect was detected during use on patient.The patient condition was reported as "fine".No patient injury/consequence or medical intervention reported.
Additional Manufacturer Narrative
(b)(4).The report that the guide wire kinked during use was confirmed through examination of the returned sample.The customer returned one swg in its advancer and the product lidstock for evaluation.The guide wire was returned within the advancer tube and showed evidence of use.The guide wire was observed to have one kink towards on the distal j-bend, and one slight bend towards the proximal end.The distal j-bend was misshapen but intact.Microscopic examination confirmed the damage in the guide wire body.Both welds were present and were observed to be full and spherical.The kink in the guide wire was located 3 mm via calibrated ruler from the distal tip.The bend was located approximately 20 mm via calibrated ruler from the proximal tip.The overall length of the guide wire measured 457 mm via calibrated ruler which was within the specification of 450-458 mm per guide wire product drawing.The outer diameter (od) of the guide wire measured 0.838 mm via calibrated micrometer which was within the specification of 0.838-0.877 mm per guide wire product drawing.Functional inspection was performed per the instructions-for-use (ifu) statement, "advance guidewire into arrow raulerson syringe approximately 10 cm until it passes through syringe valves or into introducer needle (or catheter)." the guide wire was advanced through a lab inventory ars and a lab inventory 18ga introducer needle to functionally test the guide wire.The guide wire passed through both components with little to no resistance.A manual tug test confirmed that both the distal and proximal welds were intact.The instructions-for-use (ifu) provided with the kit describes suggested techniques to minimize the likelihood of guide wire damage during use.The instructions caution, "do not apply excessive force in placing or removing guidewire, dilator, or sheath.Excessive force can cause component damage or breakage." a device history record review was performed, and no relevant findings were identified.Based on the condition of the guide wire and the report that the damage was observed during use, unintentional use error caused or contributed to this event.Teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
Customer reported the inability to advance the spring wire guide.Upon removal, the wire appeared bent/misshaped.The customer wasn't sure if this was a product defect.The reported defect was detected during use on patient.The patient condition was reported as "fine".No patient injury/consequence or medical intervention reported.

• Brand Name: PSI KIT: 9 FR X 4-1/8" (10 CM)
• Common Device Name: INTRODUCER, CATHETER
• 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: kevin don bosco ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 18473531
• Report Number: 9680794-2024-00044
• Device Sequence Number: 6407973
• Product Code: DYB
• UDI-Device Identifier: 10801902206791
• UDI-Public: 10801902206791
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K780532
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/15/2023

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 Expiration Date: 09/30/2024
• Device Catalogue Number: ASK-09903-LC2
• Device Lot Number: 33F23D0684
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/20/2023
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 01/30/2024
• Initial Report FDA Received Date: 01/09/2024
• Supplement Report FDA Received Date: 02/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/16/2023
• 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: NOT REPORTED.; NOT REPORTED.
• Patient Sex: Unknown