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

Catalog Number	CL-07924
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/08/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported "during the procedure according to ifu, md found dilator broken.So the md opened up the new kit to finish the procedure." there was no patient harm or injury.No medical intervention required.The patient's current condition is reported as "fine.".
Additional Manufacturer Narrative
(b)(4).The customer returned one dilator and sheath within a cath-lab kit for analysis.Evidence of use was observed.Visual analysis revealed that the dilator hub was completely separated from the dilator body.The separation points were rough and discolored.The condition of the separation point appears consistent to that of a stress related break.No other defects or anomalies were observed.Dimensional analysis of the dilator hub and hemostasis valve cap was performed.Both components measured out of the specified tolerances.Due to the discrepancy, the manufacturing and packaging facilities were consulted.After observing the dilator hub cross section, they confirmed that the returned dilator was milled, which aligns with a previous design of the dilator.This design is inconsistent with the dilator listed in the bill of materials (bom) for the reported kit.Due to the discrepancy, clarification was additionally requested of the customer, but no response was provided.Therefore, it was determined that the customer may have reported the incorrect material and batch as a part of this complaint.A device history record review was performed on the reported batch number and no relevant findings were identified.The customer report of a hub separated from a dilator was confirmed through complaint investigation of the returned sample.The dilator was separated directly adjacent to the hub.The material at the points of separation showed white discoloration.This discoloration appeared consistent to that of a stress related break.Consultation with the manufacturing facility and additional review of the component design revealed that the dilator and cap did not align with the reported finished good and batch.The components aligned with a previous design, which is within scope of a previously opened capa.The capa investigation indicates the root cause is likely design related.However, due to the discrepancy between the returned components and the reported batch, the root cause could not be determined at this time.Teleflex will continue to monitor and trend on reports of this nature.
Event or Problem Description
It was reported "during the procdeure according to ifu, md found dilator broken.So the md opend up the new kit to finish the procedure." there was no patient harm or injury.No medical intervention required.The patient's current condition is reported as "fine".

• 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: 20793160
• Report Number: 9680794-2024-01147
• Device Sequence Number: 7894854
• Product Code: DQY
• UDI-Device Identifier: 00801902002051
• UDI-Public: (01)00801902002051(11)230801(17)280731(10)14F23G0260(21)
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K862056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/31/2024

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-07924
• Device Lot Number: 14F23G0260
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/08/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/31/2024
• Supplement Date Received by Manufacturer: 11/27/2024
• Initial Report FDA Received Date: 11/27/2024
• Supplement Report FDA Received Date: 12/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/01/2023
• 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