MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW CATH-LAB SHEATH INTRO SET:; INTRODUCER, CATHETER

Catalog Number CP-07811

Device Problem Connection Problem (2900)

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

Event Date 01/10/2022

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

During the procedure the physician found that the dilator was not inserted into the sheath.The device was replaced.No patient harm.The patient's condition is reported as fine.

Manufacturer Narrative

Qn# (b)(4).The customer returned one dilator/sheath assembly for evaluation.No definite signs of use were observed on the sample.Visual analysis revealed the dilator body was cracked directly adjacent to the dilator hub.This resulted in the dilator hub to be partially separated from the extrusion.This defect likely contributed to the difficulty locking the dilator into the sheath during usage of the device.The total length of the dilator body measured to be 7 11/16" which is within specifications of 7 1/12"-8" per product drawing.The outer diameter of the dilator measured to be 0.107" which is within specifications of 0.107-0.110" per product drawing.The dilator inner diameter at the proximal end could not be accurately measured due to the damage; however, the inner diameter at the distal tip measured.040" which is within the specification limits of.039"-.041" per the dilator graphic.The instructions-for-use (ifu) provided with this kit instructs the user, "holding sheath in place, remove spring-wire guide and dilator".The dilator was able to advance and retract from the returned sheath with minimal resistance.Despite the damage, the hub of dilator appeared to snap into the hub of the sheath.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 guide wire 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 dilator/sheath would not lock during use was confirmed through complaint investigation.Visual analysis revealed that the dilator hub had become partially separated from the extrusion.This likely resulted in the connection difficulty encountered by the customer.The dilator passed all relevant dimensional and functional inspection, and a device history record review was performed with no relevant findings.A capa has previously been initiated to further investigate this issue.The capa investigation indicates the probable root cause is design related.Corrective actions have not yet been implemented.Teleflex will continue to monitor and trend for reports of this nature.

Event Description

During the procedure the physician found that the dilator was not inserted into the sheath.The device was replaced.No patient harm.The patient's condition is reported as fine.

• Brand Name: ARROW CATH-LAB SHEATH INTRO SET:
• Type of Device: INTRODUCER, CATHETER
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• 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: 13418522
• MDR Text Key: 286069229
• Report Number: 9680794-2022-00062
• Device Sequence Number: 1
• Product Code: DYB
• 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,Company Representative,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: CP-07811
• Device Lot Number: 14F20G0046
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/31/2022
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/28/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/24/2020
• 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