MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW MULTI-LUMEN PI CVC KIT: 3-L 7 FR X 8" (2; CATHETER INTRAVASCULAR THERAP

Model Number	IPN036438
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	Hematoma (1884)
Date of Event	03/17/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
The complaint is reported as: during insertion, the wire was unable to thread through the catheter.The user tested it initially and it was "a bit sticky" but the user tried to dilate the catheter by sliding the wire through twice.This helped a little however the user was unable to withdraw the wire through the catheter once it was placed.The catheter and wire were removed together and another catheter was placed on the opposite side.The device did not cause injury or death, but it was reported the patient had a hematoma.The patient's condition was reported as "guarded".
Event or Problem Description
The complaint is reported as: during insertion, the wire was unable to thread through the catheter.The user tested it initially and it was "a bit sticky" but the user tried to dilate the catheter by sliding the wire through twice.This helped a little however the user was unable to withdraw the wire through the catheter once it was placed.The catheter and wire were removed together and another catheter was placed on the opposite side.The device did not cause injury or death, but it was reported the patient had a hematoma.The patient's condition was reported as "guarded".
Additional Manufacturer Narrative
(b)(4).The customer returned one opened cvc kit.Signs of use in the form of biological material was observed on the guide wire.The guide wire was returned advanced through the cvc catheter.Upon dislodging the guide wire from the catheter, visual analysis revealed that the guide wire was unraveled towards the proximal end.Four major kinks were also observed.Microscopic examination confirmed the damage and revealed that the core wire had separated approximately 0.5cm from the proximal weld.The weld was still attached to the coil wire.It was noted that a major kink was observed at this separation of the core wire.This kink likely contributed to the unraveling and is consistent with undue force being applied to the guide wire during insertion/removal.Both welds appeared spherical and intact.Kinks were also observed on the catheter body; however, they correspond with the kinks on the guide wire.The total core wire length measured 601mm, which is within the specification limits of 596mm-604mm per the guide wire graphic.The guide wire outer diameter measured.797mm, which is within the specification limits of.788mm-.826mm per the guide wire graphic.The catheter body length measured 215mm, which is within the specification limits of 207mm-227mm per the catheter graphic.The guide wire outer diameter measured.0954", which is within the specification limits of.0940"-.0980" per the catheter extrusion graphic.A lab inventory guide wire with the same diameter as the guide wire packaged within the finished kit was inserted through the catheter.Little to no resistance was observed as the guide wire was able to pass completely through the catheter.Performed per ifu statement, "thread tip of multiple-lumen catheter over spring-wire guide.Sufficient spring-wire guide length must remain exposed at hub end of catheter to maintain a firm grip on spring-wire guide.Grasping near skin, advance catheter into vein with slight twisting motion".A manual tug test confirmed that the distal weld was intact.A device history record review was performed, and no relevant findings were ide ntified.The ifu provided with the kit informs the user, "although the incidence of spring-wire guide failure is extremely low, practitioner should be aware of the potential for breakage if undue force is applied to the spring-wire guide".The ifu also states, "do not apply excessive force in removing spring-wire guide or catheter.If withdrawal cannot be easily accomplished, a visual image should be obtained and further consultation requested".The report that the guide wire unraveled was confirmed through examination of the returned sample.The core wire was broken approximately 0.5cm from the proximal weld.A major kink was observed at this location which likely contributed to the damage.The returned sample met all relevant dimensional requirements, 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 user error caused or contributed to this event.Teleflex will continue to monitor and trend for reports of this nature.

• Brand Name: ARROW MULTI-LUMEN PI CVC KIT: 3-L 7 FR X 8" (2
• Common Device Name: CATHETER INTRAVASCULAR THERAP
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 11622311
• Report Number: 9680794-2021-00144
• Device Sequence Number: 11764817
• Product Code: FOZ
• UDI-Device Identifier: 10801902117189
• UDI-Public: 10801902117189
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K071538
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/17/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 10/31/2022
• Device Model Number: IPN036438
• Device Catalogue Number: CDC-45703-P1A
• Device Lot Number: 13F20M0394
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/31/2021
• Initial Date Received by Manufacturer: 03/17/2021
• Supplement Date Received by Manufacturer: 05/04/2021
• Initial Report FDA Received Date: 04/06/2021
• Supplement Report FDA Received Date: 05/05/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1