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U.S. Department of Health and Human Services

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

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ARROW INTERNATIONAL INC. ARROW CVC KIT: 3-LUMEN 7 FR X 20 CM CATHETER, INTRAVASCULAR, THERAPEUTIC Back to Search Results
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.
 
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Brand NameARROW CVC KIT: 3-LUMEN 7 FR X 20 CM
Type of DeviceCATHETER, 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 Key6418258
MDR Text Key70371006
Report Number3003737899-2017-00019
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
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
Date FDA Received03/20/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberAK-45703-CDC
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/19/2017
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 Treatment Data
Date Received: 03/20/2017 Patient Sequence Number: 1
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