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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW PI CVC KIT: 3-L 7 FR X 20 CM AGB; CATHETER INTRAVASCULAR THERAPE
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ARROW INTERNATIONAL INC. ARROW PI CVC KIT: 3-L 7 FR X 20 CM AGB; CATHETER INTRAVASCULAR THERAPE Back to Search Results
Catalog Number CDC-42703-XP1A
Device Problems Break (1069); Difficult to Remove (1528); Unraveled Material (1664)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/12/2019
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
The customer reports that the guidewire was a bit difficult to pull out and required some maneuvering.As the user was pulling it out, the wire started to uncoil and it broke.The entire wire was pulled out.The customer reports that the wire is not as stiff as previous ones.
 
Manufacturer Narrative
(b)(4).Corrected data: catalog# corrected to cdc-42703-xp1a.The customer returned one guide wire for evaluation.The catheter was not returned.Visual examination revealed the guide wire contains two kinks with the guide wire body.The core wire was also observed to have broken adjacent to the distal weld and the proximal weld appeared full and spherical.Visual inspection of the catheter could not be performed as the catheter was not returned.The kinks measured at 16mm and 344mm from the proximal end.The overall length of the broken core wire measured 603mm which is within specification of 596-604mm per product drawing; therefore no pieces of the core wire appear to be missing.The outer diameter of the guide wire measured.801mm which is within specification of.788-.826mm per product drawing.The undamaged portions of the guide wire were able to pass through an ars connected to an introducer needle with minimal resistance.A manual tug test confirmed the proximal weld was intact.A dhr review was completed with no relevant findings.The instructions-for-use (ifu) provided with this product describes suggested techniques to minimize the likelihood of guide wire damage during use.The ifu cautions that if resistance is encountered when attempting to remove the spring-wire guide after catheter placement, the spring-wire may be kinked about the tip of the catheter within the vessel which may result in undue force being applied resulting in spring wire guide breakage.If resistance is encountered, withdraw the catheter relative to the spring-wire guide about 2-3 cm and attempt to remove the spring-wire guide.If resistance is again encountered, remove the spring-wire guide and catheter simultaneously.The report that the guide wire was unraveled was confirmed through examination of the returned sample.The guide wire core wire was broken adjacent to the distal weld.Dimensional inspection and a device history record review did not reveal any evidence of a manufacturing related issue.Arrow guide wires of this size are designed and manufactured to withstand a tensile force of 2.75 pounds force.This internal specification is higher than the bs en iso 11070:2014 standard of 2.2 pounds force for this size wire.The selected insertion site and patient anatomy may present a tortuous path that could contribute to the possibility of guide wire kinking.Guide wire breakage may occur if a force greater than the design specification is applied during removal.Based on these circumstances, unintentional use error 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 for evaluation.Teleflex will continue to monitor and trend for reports of this nature.
 
Event Description
The customer reports that the guidewire was a bit difficult to pull out and required some maneuvering.As the user was pulling it out, the wire started to uncoil and it broke.The entire wire was pulled out.The customer reports that the wire is not as stiff as previous ones.
 
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Brand Name
ARROW PI CVC KIT: 3-L 7 FR X 20 CM AGB
Type of Device
CATHETER INTRAVASCULAR THERAPE
Manufacturer (Section D)
ARROW INTERNATIONAL INC.
reading PA
MDR Report Key8870946
MDR Text Key155349477
Report Number1036844-2019-00875
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
PMA/PMN Number
K071538
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 07/25/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/07/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date09/30/2020
Device Catalogue NumberCDC-42703-XP1A
Device Lot Number23F19D0079
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/21/2019
Date Manufacturer Received08/28/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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