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

Catalog Number	CS-15192-VFE
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/28/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported "when the vascular surgeon tried to peel away the smart seal sheath, it did not separate at the proximal opening, it was pried open, bit by bit and then cut alongside with scissors whilst slowly pushing the catheter along." there was no patient harm or injury.No medical intervention required.The patient's current condition is reported as "unknown".
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported "when the vascular surgeon tried to peel away the smart seal sheath, it did not separate at the proximal opening, it was pried open, bit by bit and then cut alongside with scissors whilst slowly pushing the catheter along." there was no patient harm or injury.No medical intervention required.The patient's current condition is reported as "unknown".
Additional Manufacturer Narrative
(b)(4).The actual device was not returned; however, the customer submitted two photos for analysis.The images show a 16fr smartseal sheath.The sheath extrusion is stretched and obviously manually cut.The tabs and valve remained intact and the sheath is in two parts.This damage is consistent with incorrect tearing of the sheath.Therefore, the report of incorrect tearing of a peel-away sheath is confirmed.A device history record review was performed, and there were no potential findings.The instructions for use (ifu) provided with this kit instructs the user "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 incorrect tearing of a peel-away sheath was confirmed by visual inspection of the customer supplied photos.However, full complaint verification testing could not be performed as no sample was returned for analysis.A scar was issued on (b)(6) 2024 regarding "peel-away sheath tears incorrectly".The device addressed in this complaint was manufactured on 28-june-2024.Therefore, this device was manufactured prior to final corrective action implementation, and additional corrective action is not required.Teleflex will continue to monitor and trend for reports of this nature.
Additional Manufacturer Narrative
(b)(4).The customer submitted two photos of a 16fr smartseal sheath.The sheath extrusion is stretched and obviously manually cut.The tabs and valve remained intact and the sheath is in two parts.This damage is consistent with incorrect tearing of the sheath.The customer also returned one 16fr smartseal sheath for analysis.Signs for use were observed.Visual inspection revealed that one tab of the sheath was disconnected from the rest of the sheath body.The sheath body was connected in one piece, and one of the sheath hub tabs remained attached.Cut marks were observed along the length of the body.Warping and deformation of the sheath extrusion was observed at the distal end of each of the halves of the hub.This is consistent with incorrect tearing of the sheath body.The two halves of the hemostasis valve were observed to be properly separated and secured within each half of the sheath hub.No other defects or anomalies were observed.A device history record review was performed and no relevant findings were identified.The instructions for use (ifu) provided with this kit instructs the user "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 incorrect tearing of a peel-away sheath was confirmed by investigation of the returned sample.Visual analysis revealed deformation of the sheath extrusion consistent with incorrect tearing.A scar was issued on 11-apr-2024 regarding "peel-away sheath tears incorrectly".The device addressed in this complaint was manufactured on 28-june-2024.Therefore, this device was manufactured prior to final corrective action implementation, and additional corrective action is not required.Teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
It was reported "when the vascular surgeon tried to peel away the smart seal sheath, it did not separate at the proximal opening, it was pried open, bit by bit and then cut alongside with scissors whilst slowly pushing the catheter along." there was no patient harm or injury.No medical intervention required.The patient's current condition is reported as "unknown".

• Brand Name: ARROW HEMODIALYSIS SET: 2-L 15 FR X 19 CM RETR
• 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: 21976875
• Report Number: 9680794-2025-00385
• Device Sequence Number: 7227822
• Product Code: MSD
• UDI-Device Identifier: 10801902127171
• UDI-Public: (01)10801902127171(11)240528(17)270430(10)33F24D1003(21)
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: K141051
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/16/2025

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 Catalogue Number: CS-15192-VFE
• Device Lot Number: 33F24D1003
• 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: 04/16/2025
• Supplement Date Received by Manufacturer: 06/02/2025; 11/12/2025
• Initial Report FDA Received Date: 05/07/2025
• Supplement Report FDA Received Date: 06/10/2025; 11/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/28/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: NOT REPORTED; NOT REPORTED; NOT REPORTED
• Patient Age: 65 YR
• Patient Sex: Male