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

Catalog Number CL-07645

Device Problem Obstruction of Flow (2423)

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

Event Date 06/30/2022

Event Type  malfunction  

Event Description

It was reported the catheter was found blocked during patient use.No patient harm reported.The patient's condition is reported as fine.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

Qn#(b)(4).The customer returned one cath-lab sheath set for evaluation.Initial visual inspection of the sheath did not reveal any defects or anomalies.The total length of the sheath body measured 17.8125", which is within specifications of 17.125- 18.125" per sheath graphic.The outer diameter of the sheath body measured 0.11440" which is within specifications of 0.111-0.115" per sheath graphic.The inner diameter of the sheath tip measured 0.086", which is within specifications of 0.085-0.087" per sheath graphic.The sheath was functionally tested per the instructions for use (ifu).The ifu provided with this kit states, "prepare sheath for insertion by flushing through side arm." and "ensure dilator hub fully snaps into sheath cap." the sheath was able to be flushed with a lab inventory syringe through the side arm with no issues when the dilator was not inserted.The returned dilator was able to be advanced and retracted with no issues.The dilator was also able to snap into the sheath hub.A device history record review was performed, and no relevant findings were found.The complaint of a sheath blocked was not able to be confirmed by investigation of the returned sample.The sheath passed all dimensional and functional testing.No blockages or damage was observed with the returned device.A device history record review was performed, and no relevant findings were found.Based on the sample returned, no problem was identified.Teleflex will continue to monitor and trend on complaints of this nature.

Event Description

It was reported the catheter was found blocked during patient use.No patient harm reported.The patient's condition is reported as fine.

• 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: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 15195012
• MDR Text Key: 301738552
• Report Number: 9680794-2022-00479
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: 07/19/2022

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-07645
• Device Lot Number: 14F20L0164
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/08/2022
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/19/2022
• Initial Date FDA Received: 08/09/2022
• Supplement Dates Manufacturer Received: 09/02/2022
• Supplement Dates FDA Received: 09/07/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/07/2021
• 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: NOT REPORTED.; NOT REPORTED.