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

Catalog Number CL-07624

Device Problem Material Twisted/Bent (2981)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/13/2024

Event Type  malfunction  

Manufacturer Narrative

Qn#(b)(4).

Event Description

It was reported "during the procedure according to ifu, the md found tip of the dilator to be bent.So the md opend up the new kit to finish the procedure." no patient harm or injury.No medical intervention required.The pateint's current condition is reported as "fine".

Event Description

It was reported "during the procedure according to ifu, the md found tip of the dilator to be bent.So the md opened up the new kit to finish the procedure." no patient harm or injury.No medical intervention required.The patient's current condition is reported as "fine".

Manufacturer Narrative

(b)(4), the customer returned one opened cath-lab sheath introducer set for evaluation.Signs-of-use were observed on the returned components.Visual inspection of the dilator tip was split and frayed.The damage appears consistent with undue force applied to the dilator during an attempted insertion.The dilator total length measured 13" which is within the specifications of 12 1/2"-13 1/4" per product drawing.The dilator inner diameter at the tip could not be accurately measured due to the damage.Functional inspection of the dilator was performed per the instructions-for-use (ifu) provided with the kit, which states "ensure dilator hub fully snaps into sheath cap." the dilator was able to fully thread into the sheath with no resistance.A device history record review was performed with no relevant findings.The instructions for use (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 damaged dilator tip was confirmed through complaint investigation of the returned sample.Visual inspection revealed the dilator tip was frayed.The damage appears consistent with undue force being applied to the dilator during an attempted insertion.The returned dilator met all relevant dimensional and functional requirements, and a device history record review was performed with no relevant findings.Based on these circumstances, unintentional use error likely caused or contributed to this event.Teleflex will continue to monitor and trend for complaints 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: keona jones ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 19164010
• MDR Text Key: 341356036
• Report Number: 9680794-2024-00359
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 00801902001825
• UDI-Public: 00801902001825
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: K862056
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/27/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/23/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: CL-07624
• Device Lot Number: 14F23F0264
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/08/2024
• Date Manufacturer Received: 03/27/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/29/2023
• 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