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

Model Number	IPN920048
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/25/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported "long sheath introducer - valve broke off".The catheter was removed by the physician by hand and the physician made a manual compression hemostasis successfully.No patient harm was reported.The patient's condition is reported to be fine.
Additional Manufacturer Narrative
Qn#(b)(4).
Event or Problem Description
It was reported "long sheath introducer - valve broke off".The catheter was removed by the physician by hand and the physician made a manual compression hemostasis successfully.No patient harm was reported.The patient's condition is reported to be fine.
Additional Manufacturer Narrative
(b)(4).The customer provided two images for analysis.The images reveal the separated sheath body and lidstock details.The customer also returned one sheath and product lidstock for analysis.Definite signs of use in the form of biomaterial were observed on the sheath.Visual analysis revealed that the sheath extrusion was separated from the hemostasis valve directly adjacent to the juncture hub.The hemostasis valve body was also observed to be slightly cracked/chipped.Microscopic examination of the point of separation revealed that the sheath extrusion was slightly stretched.The overall length of the sheath extrusion measured 26", which is within the specification limits of 25" - 26" per the sheath/dilator assembly drawing.The outer diameter of the sheath body measured 0.1265", which is within the specification limits of 0.124" - 0.128" per the wrapped sheath extrusion graphic.Functional inspection could not be performed due to the separation of the returned device.The manufacturing facility was previously contacted regarding defects of this nature.They indicated that based on the appearance of the point of separation, the sheath was properly attached to the hub.They also indicated that the damage appears consistent with undue force being applied during use.A device history record review was performed and no relevant findings were identified.The instructions for use (ifu) provided with this 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." the customer report of a sheath body separation was confirmed through investigation of the returned sample.Visual analysis revealed that the sheath body had become separated directly adjacent to the connection point at the juncture hub.The components passed all relevant dimensional requirements.A device history record review was performed, and no relevant findings were identified.Based on the customer report, the sample received, and the comments from the manufacturing facility, unintentional use error likely caused or contributed to this event.Teleflex will continue to monitor and trend for reports of this nature.

• 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: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 16966282
• Report Number: 9680794-2023-00355
• Device Sequence Number: 5238539
• Product Code: DQY
• UDI-Device Identifier: 10801902192490
• UDI-Public: 10801902192490
• Combination Product (Y/N): N
• PMA/510(K) Number: K862056
• 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
• Report Date (Section B): 04/28/2023

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
• Operator of Device: Health Professional
• Device Model Number: IPN920048
• Device Catalogue Number: CL-07765
• Device Lot Number: 14F22H0311
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/10/2023
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/28/2023
• Supplement Date Received by Manufacturer: 06/09/2023
• Initial Report FDA Received Date: 05/19/2023
• Supplement Report FDA Received Date: 06/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/13/2022
• 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 Age: 64 YR
• Patient Sex: Male