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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW MULTI-LUMEN PI CVC KIT: 3-L 7 FR X 8" CATHETER, INTRAVASCULAR, THERAPEUTIC
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ARROW INTERNATIONAL INC. ARROW MULTI-LUMEN PI CVC KIT: 3-L 7 FR X 8" CATHETER, INTRAVASCULAR, THERAPEUTIC Back to Search Results
Catalog Number CDC-45703-P1A
Device Problem Kinked (1339)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/01/2017
Event Type  malfunction  
Manufacturer Narrative
(b)(4). The customer returned one guide wire for evaluation. The catheter was not returned. The guide wire was kinked and showed evidence of use. Visual examination revealed the guide wire is kinked in two locations in the guide wire body. The distal j-bend is undamaged. Microscopic examination of the guide wire confirmed the kinks. Offset coils were observed in one of the kinks. Both welds appeared full and spherical. Visual inspection of the catheter could not be performed as the catheter was not returned. The kinks in the guide wire body were measured at 20. 3 and 30. 2cm from proximal weld. The guide wire overall length measured 603mm, which is within specification. The outside diameter (od) of the guide wire was measured and found to be within specification. A manual tug test confirmed that both the distal and proximal welds were intact. A device history record (dhr) review was performed on the guide wire and catheter and no relevant manufacturing issues were identified. Other remarks: the instructions-for-use provided with this kit describes suggested techniques to minimize the likelihood of guide wire damage during use. The ifu states that if resistance is encountered when attempting to remove the spring wire guide after catheter placement, the spring wire guide may be kinked about the tip of the catheter within the vessel. In this circumstance, withdraw the catheter relative to the spring wire guide about 2-3cm and attempt to remove the spring wire guide. If resistance is again encountered, remove the spring wire guide and catheter simultaneously. The reported complaint of the guide wire becoming kinked while removing from the catheter was confirmed through visual inspection of the returned sample. Multiple kinks were observed on the returned guide wire; however, the catheter was not returned for evaluation. A dhr review did not reveal any manufacturing related issues. No manufacturing defects were found during this investigation. Based on these circumstances, it was determined that operational context likely contributed to this event, however, the probable cause of guide wire and catheter resistance could not be determined based upon the information provided and without the catheter being returned.
 
Event Description
The customer reports that when the md pulled out the wire it got stuck and finally came out. The wire was extremely kinked. There was no injury or consequence to the patient reported. The patient's condition is reported as "fine". Therapy was reported to have been delayed/interrupted due to the alleged defect.
 
Manufacturer Narrative
(b)(4).
 
Event Description
The customer reports that when the md pulled out the wire it got stuck and finally came out. The wire was extremely kinked. There was no injury or consequence to the patient reported. The patient's condition is reported as "fine". Therapy was reported to have been delayed/interrupted due to the alleged defect.
 
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Brand NameARROW MULTI-LUMEN PI CVC KIT: 3-L 7 FR X 8"
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 Key6707599
MDR Text Key176781468
Report Number3003737899-2017-00068
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
Type of Report Initial,Followup
Report Date 07/07/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/12/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date06/30/2018
Device Catalogue NumberCDC-45703-P1A
Device Lot Number13F16K0326
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/17/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/24/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/29/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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