MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW HEMODIALYSIS SET: 2-L 15 FR X 19 CM ANTE; CATHETER, HEMODIALYSIS, IMPLA

Catalog Number	CS-15192-VFIE
Medical Device Problem Codes	Break (1069); Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/20/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn#(b)(4).
Event or Problem Description
It was reported "according to the doctor the butterfly sheath broken and hemostatic valve came out." the device was removed and replaced.There was no patient harm or injury.The patient's current condition is reported as "fine".
Event or Problem Description
It was reported "according to the doctor the butterfly sheath broken and hemostatic valve came out." the device was removed and replaced.There was no patient harm or injury.The patient's current condition is reported as "fine".
Additional Manufacturer Narrative
Qn#(b)(4).The actual device was not returned; however, the customer provided one photo for analysis.Definite signs of use were observed on the sheath.The sheath extrusion was torn down the entire length of the extrusion along one side.The photo revealed that the point of tearing was irregular and not along the intended score lines.The seal was additionally separated from the sheath assembly, which may be correlated with the sheath tearing incorrectly.Despite this, the sheath extrusion was still molded to both tabs.Therefore, based on the customer photo, the complaint of a sheath tearing incorrectly was able to be confirmed.A device history record review was performed and relevant findings were identified.For material number c-70013-003, a supplier corrective action request (scar) was opened for the failure mode "peel away tears incorrectly".The instructions for use (ifu) provided with this kit informs the user, "precaution: dilators and catheters should be removed slowly from sheath.Rapid removal may damage valve resulting in blood flow through valve.Never advance or withdraw guidewire or sheath when resistance is met.Determine cause by fluoroscopy and take remedial action.Sharply snap the tabs of valve housing in a plane perpendicular to the long axis of sheath to split valve and split sheath apart while withdrawing from vessel." the customer report of a sheath tearing incorrectly was confirmed by a complaint investigation of the customer photo.The returned sheath did not separate along the score lines as intended.The sheath is manufactured by a third-party supplier.A device history record review additionally revealed relevant supplier related findings.Therefore, based on the investigation performed, the supplier caused or contributed to this defect.A non-conformance was initiated to further investigate this issue.Teleflex will continue to monitor and trend on complaints of this nature.
Additional Manufacturer Narrative
(b)(4).One unit of sheath was returned for analysis.The sheath extrusion was torn down the entire length of the extrusion along one side.The point of tearing was irregular and not along the intended score lines.A wavy pattern could be observed.The separated seal as reported by the customer was not returned for evaluation.The remainder half was present on one of the sides of the hub tab.This half was slightly depressed from its original position that is indicative of operational manipulation of hub in correlation to the sheath tearing incorrectly.Sheath extrusion was molded to the tabs.No functional inspection could be performed as the unit was already split and damaged.A device history record review was performed and relevant findings were identified.For material number: c-70013-003, a scar was opened for the failure mode "peel away tears incorrectly".The instructions for use (ifu) provided with this kit informs the user, "precaution: dilators and catheters should be removed slowly from sheath.Rapid removal may damage valve resulting in blood flow through valve.Never advance or withdraw guidewire or sheath when resistance is met.Determine cause by fluoroscopy and take remedial action.Sharply snap the tabs of valve housing in a plane perpendicular to the long axis of sheath to split valve and split sheath apart while withdrawing from vessel." based on the investigation performed, the reported complaint was confirmed.The most likely root cause of the issue is supplier related.A scar was previously opened to address this issue.Teleflex will continue to monitor similar issues and trends.
Event or Problem Description
It was reported "according to the doctor the butterfly sheath broken and hemostatic valve came out." the device was removed and replaced.There was no patient harm or injury.The patient's current condition is reported as "fine".

• Brand Name: ARROW HEMODIALYSIS SET: 2-L 15 FR X 19 CM ANTE
• Common Device Name: CATHETER, HEMODIALYSIS, IMPLA
• Manufacturer (Section D): ARROW INTERNATIONAL LLC; morrisville NC
• Manufacturer (Section G): ARROW INTERNATIONAL DE MEXICO S.A. DE C.V.; ave. washington 3701; colonia panamericana, chihuahua; chihuahua 31200 ; MX 31200
• Manufacturer Contact: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 20843386
• Report Number: 9680794-2024-01198
• Device Sequence Number: 3928362
• Product Code: MSD
• UDI-Device Identifier: 10801902127195
• UDI-Public: (01)10801902127195(11)231012(17)260930(10)33F23K0169(21)
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K141051
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/12/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2026
• Device Catalogue Number: CS-15192-VFIE
• Device Lot Number: 33F23K0169
• 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: 11/12/2024
• Supplement Date Received by Manufacturer: 12/30/2024; 11/26/2025
• Initial Report FDA Received Date: 12/04/2024
• Supplement Report FDA Received Date: 01/06/2025; 12/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/12/2023
• 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.; NOT REPORTED.
• Patient Sex: Unknown