MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW CVC KIT: 3-LUMEN 7 FR X 20 CM; CATHETER, INTRAVASCULAR, THERAPEUTIC

Catalog Number AK-45703-CDC

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

Patient Problems Dyspnea (1816); Pain (1994); Foreign Body In Patient (2687)

Event Date 02/28/2017

Event Type  Injury  

Manufacturer Narrative

Qn#(b)(4).The user facility (pathology dept.) is not willing to release the device sample.The risk manager reports that the device in question did not contribute to the injury of the patient.

Event Description

The customer reports that a central line procedure was performed on (b)(6) 2016.On (b)(6) 2017 the patient returned to the hospital with arm and shoulder pain and shortness of breath.A ct scan was ordered and a 28cm of a guidewire was discovered under the clavicle.Intervention - a central venogram with foreign body retrieval was performed to remove the wire.The patient had no further issues after the wire was removed.The patient's condition is reported as stable.The risk manager stated that the device in question did not contribute to the injury to the patient.

Manufacturer Narrative

Qn#(b)(4).The sample was not returned for evaluation.A device history record (dhr) review could not be performed as a lot number was not provided by the customer and there was no record of direct sales history of this product to this customer.The instructions for use (ifu) was reviewed as part of this complaint investigation.The ifu describes suggested techniques to minimize the likelihood of guide wire damage during use.The instructions caution that withdrawing the guide wire against the needle bevel or use of excessive force during removal could damage or break the wire.The ifu also contains the step to always verify the entire guide wire is intact upon removal.Complaint verification testing could not be performed as no sample was returned for analysis.The probable cause of the guide wire separating and remaining in the patient could not be determined based upon the information provided and without a sample.

Event Description

The customer reports that a central line procedure was performed on (b)(6) 2016.On (b)(6) 2017 the patient returned to the hospital with arm and shoulder pain and shortness of breath.A ct scan was ordered and a 28cm of a guidewire was discovered under the clavicle.Intervention - a central venogram with foreign body retrieval was performed to remove the wire.The patient had no further issues after the wire was removed.The patient's condition is reported as stable.The risk manager stated that the device in question did not contribute to the injury to the patient.

• Brand Name: ARROW CVC KIT: 3-LUMEN 7 FR X 20 CM
• Type of Device: CATHETER, INTRAVASCULAR, THERAPEUTIC
• 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: 6418258
• MDR Text Key: 70371006
• Report Number: 3003737899-2017-00019
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date: 03/03/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Catalogue Number: AK-45703-CDC
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/03/2017
• Initial Date FDA Received: 03/20/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/20/2017
• 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