MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW MULTI-LUMEN/PSI KIT; INTRODUCER CATHETER

Catalog Number AK-21242-CDC

Device Problem Device Dislodged or Dislocated (2923)

Patient Problems Ventricular Fibrillation (2130); No Known Impact Or Consequence To Patient (2692); No Information (3190)

Event Date 04/01/2019

Event Type  Injury  

Manufacturer Narrative

Qn# (b)(4).Lot# unknown.Potential lot# 13f18l0271.Additional information requested from the user facility.No additional information received at the time of this report.Complaint verification testing could not be performed as no sample was returned for analysis.A device history record review was performed, and no relevant findings were identified.Without the device to evaluate, the complaint could not be confirmed, and the probable cause could not be determined from the available information.The ifu provided with this kit warns the user "do not reposition tuohy-borst adapter end on insertion catheter once moved to this final position, do not overtighten tuohy-borst adapter to minimize the risk of lumen constriction or insertion catheter damage and do not apply tape to the transparent sheathing on the shield to minimize the risk of tearing material.".Teleflex will continue to monitor and trend for reports of this nature.

Event Description

The rubber band device in the contamination guard is breaking leading to catheter migration which has resulted in patients ending up in v-fib.

• Brand Name: ARROW MULTI-LUMEN/PSI KIT
• Type of Device: INTRODUCER CATHETER
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• Manufacturer (Section G): ARROW INTERNACIONAL DE CHIHUAHUA S.A. DE C.V; ave. washington 3701, edificio 4; colonia complejo industrial, las americas; chihuahua 31114 ; MX 31114
• Manufacturer Contact: margie burton, rn ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9194334965
• MDR Report Key: 8568648
• MDR Text Key: 143677297
• Report Number: 9680794-2019-00147
• Device Sequence Number: 1
• Product Code: DYB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K011761
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/01/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: AK-21242-CDC
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/11/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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