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

Catalog Number	CL-07924
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/06/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn(b)(4).
Event or Problem Description
It was reported the sheath was inserted into the femoral vein, and when removing the dilator the hemostatic valve came out with it, causing bleed back.There was no harm to the patient.The issue was resolved by using a different brand of sheath.The patient was "stable and fine when the case finished".
Event or Problem Description
It was reported the sheath was inserted into the femoral vein, and when removing the dilator the hemostatic valve came out with it, causing bleed back.There was no harm to the patient.The issue was resolved by using a different brand of sheath.The patient was "stable and fine when the case finished".
Additional Manufacturer Narrative
Qn#(b)(4).The report of a sheath valve separation could not be confirmed through complaint investigation.The customer returned ten, unopened psi kits for analysis.No evidence of a sterility breach was observed on any of the kits.Based on the customer report that the defect was observed "during use", it was assumed that the returned samples are representative samples.Initial visual analysis did not reveal any defects or anomalies on any of the sheaths or dilators.All ten of the returned kits were opened to analyse the sheath/dilators.No defects or anomalies were observed on the valve assembly from any of the kits.Visual analysis could not be performed on the actual assemblies involved with this complaint as they were not returned.The customer also reported of a dilator hub separation which was addressed with another complaint file.Dimensional analysis was not required as part of this complaint investigation as the actual device involved was not returned for analysis.The dilators from all kits were inserted through the respective sheaths as per ifu statement, "ensure dilator hub fully snaps into sheath cap".Little to no resistance or issues were encountered as the dilator passed completely through the sheath assembly.It was noted that the dilator hub snapped into the sheath valve with no issue.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".A device history record review was performed, and no relevant findings were identified.Based on the customer report and the sample received, the root cause could not be determined as the actual device involved with this complaint was not returned for analysis.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: kevin don bosco ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 17434170
• Report Number: 9680794-2023-00543
• Device Sequence Number: 8941996
• Product Code: DQY
• UDI-Device Identifier: 00801902002051
• UDI-Public: 00801902002051
• Combination Product (Y/N): N
• Initial Reporter State: HI
• Initial Reporter Country: US
• PMA/510(K) Number: K862056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/06/2023

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-07924
• Device Lot Number: 14F23C0188
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/25/2023
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/06/2023
• Supplement Date Received by Manufacturer: 08/23/2023
• Initial Report FDA Received Date: 08/01/2023
• Supplement Report FDA Received Date: 08/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/27/2023
• 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