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

Catalog Number AK-11142

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Perforation (2001); Injury (2348); No Known Impact Or Consequence To Patient (2692)

Event Date 07/16/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

The customer alleges that the dilator sheath perforated the wall of the internal jugular vein into the subclavian artery.Intervention - open sternotomy followed by direct pressure on the puncture arterial vessel, followed by repair of the artery.

Manufacturer Narrative

(b)(4).No lot number was provided by the customer; therefore, a device history record (dhr) review was performed based upon a lot number from the sales history data of the customer.No relevant findings were identified.Complaint verification testing could not be performed as no sample was returned for analysis.Without the device to evaluate the complaint could not be confirmed and the probable ca use could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.

Event Description

The customer alleges that the dilator sheath perforated the wall of the internal jugular vein into the subclavian artery.Intervention - open sternotomy followed by direct pressure on the puncture arterial vessel, followed by repair of the artery.

• Brand Name: ARROW MULTI-LUMEN/PSI KIT
• Type of Device: CATHETER,INTRAVASCULAR,THERAP
• 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: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9194334854
• MDR Report Key: 6673964
• MDR Text Key: 78604007
• Report Number: 3003737899-2017-00061
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K002507
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: AK-11142
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/03/2017
• 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
• Patient Outcome(s): Required Intervention