MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW CVC SET: 3-LUMEN 7 FR X 16 CM; CATHETER, PERCUTANEOUS

Catalog Number CS-12703

Device Problem Device Slipped (1584)

Patient Problem Achalasia (1692)

Event Date 11/21/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).It is reported that the event is not considered to be related to the course or outcome.The customer reports taking an x-ray to exclude pneumothorax, hemothorax and other problems.

Event Description

The customer alleges the guide wire slipped into the patient in its entirety.The patient expired shortly after arrival to intensive care despite adequate treatment.The event is not considered to be related to the course or outcome.

Manufacturer Narrative

(b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.A device history record review could not be performed as a lot number was not provided by the customer.Without the device to evaluate the complaint could not be confirmed and the probable cause 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 the guide wire slipped into the patient in its entirety.The patient expired shortly after arrival to intensive care despite adequate treatment.The event is not considered to be related to the course or outcome.

• Brand Name: ARROW CVC SET: 3-LUMEN 7 FR X 16 CM
• Type of Device: CATHETER, PERCUTANEOUS
• 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 ; 9194334854
• MDR Report Key: 7121968
• MDR Text Key: 94990551
• Report Number: 9680794-2017-00287
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: NO
• PMA/PMN Number: K862056
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/23/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Catalogue Number: CS-12703
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/12/2018
• 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): Other