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

Catalog Number CL-07611

Device Problem Material Separation (1562)

Patient Problems Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/25/2024

Event Type  Injury  

Manufacturer Narrative

Qn # (b)(4).

Event Description

It was reported "during sheath removal, the hub of the sheath separated from the body of the introducer.The team was able to successfully remove the retained piece of sheath without surgical intervention." no patient harm or injury.No medical intervention required.The patients current condition is reported as "fine".

Event Description

It was reported "during sheath removal, the hub of the sheath separated from the body of the introducer.The team was able to successfully remove the retained piece of sheath without surgical intervention." no patient harm or injury.No medical intervention required.The patients current condition is reported as "fine".

Manufacturer Narrative

Qn#(b)(4).The customer returned one sheath extension assembly from the sheath ext assy w/ dilator assembly for analysis.The dilator was not returned.Signs of use in the form of biological material were observed on and within the sample.Visual inspection revealed that the sheath extrusion was separated from the hemostasis valve directly adjacent to the juncture hub.Microscopic evaluation of the separation point on the sheath revealed the sheath extrusion appeared stretched which is consistent with undue force being applied during use.The length of the separated sheath measured 4 6/8", which is within the specification limits of 3 7/8" - 4 6/8" per sheath ext assy w/ dilator product drawing.The outer diameter the sheath body measured 0.114", which is within the specification limits of 0.111"-0.115" per wrapped sheath extrusion graphic.The inner diameter of the sheath measured could not be accurately measured due to the nature of the damage.Functional testing of the sheath could not be performed due to the nature of the damage.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 ifu provided with this kit warns 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 separated directly adjacent to the connection point at the juncture hub.A device history record review was performed, and no relevant findings were identified to suggest a manufacturing issue.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
• Type of Device: 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: 19164398
• MDR Text Key: 340840683
• Report Number: 9680794-2024-00355
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 00801902001818
• UDI-Public: 00801902001818
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K862056
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 03/27/2024

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
• Device Operator: Health Professional
• Device Catalogue Number: CL-07611
• Device Lot Number: 14F23L0168
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/16/2024
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/27/2024
• Initial Date FDA Received: 04/23/2024
• Supplement Dates Manufacturer Received: 05/01/2024
• Supplement Dates FDA Received: 05/14/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/28/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: NONE REPORTED; NONE REPORTED
• Patient Age: 81 YR
• Patient Sex: Female
• Patient Weight: 36 KG
• Patient Race: White