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

Catalog Number	CL-07711
Medical Device Problem Codes	Difficult to Remove (1528); Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/08/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4) the customer provided three photos for investigation.The complaint of sheath body separation was able to be confirmed from the customer supplied photos as the first and third photos revealed that the sheath body was missing from valve sheath hub.The second photo revealed the lidstock information.The customer also returned the sheath valve body with the side arm attached for investigation.The sheath body was not returned.Signs of use in the form of biological material were observed within the sample.Visual inspection confirmed that the sheath body extrusion had been separated from the hemostasis valve at the juncture hub.The separated sheath body was not returned for investigation.Microscopic evaluation of the point of separation on the juncture hub revealed a complete separation of the sheath body.Biological material was observed within the hub.Functional testing of the sheath could not be performed due to the nature of the damage.The manufacturing facility was consulted regarding this complaint.Manufacturing site personnel indicated that based on the cross-section of the hub, the hub was properly molded during assembly.Evaluation of the sheath body could not be performed since it was not returned for investigation.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 sheath body separation was confirmed through investigation of the returned sample.Visual inspection confirmed that the sheath body extrusion had been separated from the hemostasis valve at the juncture hub.The separated sheath body was not returned for investigation.Microscopic evaluation of the point of separation on the juncture hub revealed a complete separation of the sheath body.A device history record review was performed, and no relevant findings were identified that would suggest a manufacturing issue.The manufacturing facility was consulted regarding this complaint and indicated that based on the cross-section of the hub, the hub was properly molded during assembly.Therefore, based on the incomplete sample that was returned, the root cause cannot be determined.Teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
It was reported that: "patient prepared for sheath removal.Patient with right femoral artery 7f coiled sheath.At start of right femoral artery sheath removal with pulling of the sheath, port broke away from coiled sheath.Unable to remove coiled sheath.Consequences to patient: patient taken to the or for intervention.The patient was reported as fine post the procedure.".
Event or Problem Description
It was reported that: "patient prepared for sheath removal.Patient with right femoral artery 7f coiled sheath.At start of right femoral artery sheath removal with pulling of the sheath, port broke away from coiled sheath.Unable to remove coiled sheath.Consequences to patient: patient taken to the or for intervention.The patient was reported as fine post the procedure.".
Additional Manufacturer Narrative
Qn#(b)(4).

• 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: 20608897
• Report Number: 9680794-2024-01084
• Device Sequence Number: 20869184
• Product Code: DQY
• UDI-Device Identifier: 00801902001894
• UDI-Public: (01)00801902001894(11)240809(17)290731(10)14F24G0089(21)
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K862056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/11/2024

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
• Operator of Device: Health Professional
• Device Catalogue Number: CL-07711
• Device Lot Number: 14F24G0089
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/16/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/11/2024
• Supplement Date Received by Manufacturer: 11/05/2024
• Initial Report FDA Received Date: 11/05/2024
• Supplement Report FDA Received Date: 11/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/09/2024
• 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
• Patient Age: 81 YR
• Patient Sex: Male
• Patient Weight: 88 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White