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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-45703-XP1A
Device Problem Unraveled Material (1664)
Patient Problem Hematoma (1884)
Event Date 02/13/2021
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
Customer reports that during insertion, the wire had 3 45-90 degree kinks and almost became stuck in the patient.Customer noted that the wire became uncoiled and almost became stuck in the patient and reports that it caused a hematoma in the patient.
 
Manufacturer Narrative
Qn#(b)(4).The customer returned one guide wire, one cvc catheter, and the lidstock for analysis.Signs-of-use were observed inside the distal extension line.The sample was returned with the guide wire still inserted through the distal extension line of the catheter.Visual examination revealed the guide wire was separated and unraveled towards the proximal end.Several kinks were also observed across the guide wire.Microscopic examination confirmed the damage and revealed that the core wire and the coils had separated approximately 1cm from the proximal weld.The proximal weld was still attached to both the coils and core wires on the separation section.Several offset coils were observed adjacent to the separation, which likely contributed to the damage.The guide wire cumulative core length from the distal weld to the proximal weld (added two separated pieces) measured 601mm, which is within the specification limits of 596mm-604mm per the guide wire graphic.The guide wire outer diameter measured.79mm, which is within the specification limits of.788mm-.826mm per the guide wire graphic.The catheter body outer diameter measured 217mm, which is within the specification limits of 207mm-227mm per the catheter graphic.The catheter body outer diameter measured.0945", which is within the specification limits of.094"-.098" per the catheter extrusion graphic.A lab inventory guide wire with a diameter of.032" was inserted through the returned catheter.Little to no resistance was observed.Performed per the ifu statement, "thread tip of catheter over guidewire.Sufficient guidewire length must remain exposed at hub end of catheter to maintain a firm grip on guidewire".Despite the separation, the distal and proximal welds were secure to their respective core wires.A device history record review was performed, and no relevant findings were identified.The ifu provided with the kit informs the user, "do not use excessive force when introducing guidewire or tissue dilator as this can lead to vessel perforation, bleeding, or component damage".The ifu also states, "do not withdraw guidewire against needle bevel to reduce risk of possible severing or damaging of guidewire".The customer report of guide wire separation was confirmed by complaint investigation of the returned sample.The guide wire was separated and unraveled towards the proximal end.The sample passed dimensional inspection, and a device history record review was performed with no relevant findings.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 (undue force) likely contributed to this event.Teleflex will continue to monitor and trend for reports of this nature.
 
Event Description
Customer reports that during insertion, the wire had 3 45-90 degree kinks and almost became stuck in the patient.Customer noted that the wire became uncoiled and almost became stuck in the patient and reports that it caused a hematoma in the patient.
 
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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 Key11399923
MDR Text Key234286324
Report Number1036844-2021-00033
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,user f
Type of Report Initial,Followup
Report Date 02/15/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date10/31/2021
Device Catalogue NumberCDC-45703-XP1A
Device Lot Number23F20D0153
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/23/2021
Initial Date Manufacturer Received 02/15/2021
Initial Date FDA Received03/02/2021
Supplement Dates Manufacturer Received03/29/2021
Supplement Dates FDA Received03/31/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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