MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW CATH-LAB SHEATH INTRO SET; CATHETER PERCUTANEOUS

Catalog Number	CL-07965
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/18/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that: the hemostasis valve of the sheath snapped off and got detached during use.Therefore, the sheath was removed and replaced with a new kit.No injury to the patient occurred.Additional information: when the user removed the catheter from the sheath, a part of the hemostasis valve got detached and removed with the catheter.
Additional Manufacturer Narrative
(b)(4).
Additional Manufacturer Narrative
Qn#(b)(4).The customer complaint of a valve assembly separation was confirmed through complaint investigation of the returned sample.The customer returned one psi sheath assembly for analysis.Signs-of-use in the form of biological material were observed inside the distal tip.Initial visual inspection of the sheath did not reveal any obvious defects or anomalies.The valve cap (w-08903-002c) appeared secure and intact to the hemostasis valve body (w-08803-009g); however, further analysis revealed that the internal seal (s-08803-003) was outside of the hemostasis valve body and located over the dilator.The seal is intended to rest inside the valve body.Further functional analyses revealed that the internal seal exits the proximal opening of the cap when removing the dilator from the assembly.No physical defects or anomalies were observed with any portion of the psi, the dilator, or the cap.The inner diameter of the hemostasis cap measured 0.175" via calibrated pin gauge, which was within specifications of 0.174"-0.177" per cap valve graphic.Further dimensional analysis was performed with a keyence microscope.Microscopic dimensional analysis revealed that the slits on the seal measured 0.0224", 0.0239", and 0.0212", which was not equal to the nominal value of 0.040" per the seal product drawing.The cap was able to be removed without causing any unnecessary damage to the sample.The seal was then placed within the hemostasis valve.Functional inspection was performed per instructions-for-use (ifu) provided with this kit which states, "ensure dilator hub fully snaps into sheath cap".The cap was reassembled.The dilator was inserted through the sheath.Slight resistance was encountered from inside the hemostasis valve; however, the dilator was able to fully advance and snap into the cap, which is the intended function.Upon removal of the dilator, the internal seal was observed clinging to the surface of the dilator.This resulted in the internal seal to completely exit through the cap of the hemostasis valve.The internal seal was inserted back over the dilator body.Minor resistance was encountered as the seal passes over the extrusion.The ifu provided with the kit informs the user, "do not apply excessive force in removing guidewire or sheath/dilator.If withdrawal cannot be easily accomplished, determine cause using fluoroscopic guidance and request further consultation, if necessary".Despite the damage, a device history record review did not reveal any relevant findings.Based on the customer report, the sample received, and the comments from manufacturing, the root cause is likely supplier related.Further investigation has been initiated under teleflex's quality system by the manufacturing site to further investigate this issue.Teleflex will continue to monitor and trend on complaints of this nature.
Event or Problem Description
It was reported that: the hemostasis valve of the sheath snapped off and got detached during use.Therefore, the sheath was removed and replaced with a new kit.No injury to the patient occurred.Additional information: when the user removed the catheter from the sheath, a part of the hemostasis valve got detached and removed with the catheter.Associated to 9680794-2024-00053.

• Brand Name: ARROW CATH-LAB SHEATH INTRO SET
• Common Device Name: CATHETER PERCUTANEOUS
• 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: kevin don bosco ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 18491857
• Report Number: 9680794-2024-00052
• Device Sequence Number: 6985302
• Product Code: DQY
• UDI-Device Identifier: 00801902002075
• UDI-Public: 00801902002075
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K862056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/18/2023

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 Catalogue Number: CL-07965
• Device Lot Number: 14F23G0230
• 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: 12/18/2023
• Supplement Date Received by Manufacturer: 02/06/2024
• Initial Report FDA Received Date: 01/11/2024
• Supplement Report FDA Received Date: 02/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/03/2023
• 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