MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW CVC SET: 2-LUMEN 7FR X 20CM; CATHETER, PERCUTANEOUS

Catalog Number JP-17702-C

Device Problems Material Deformation (2976); Physical Resistance/Sticking (4012)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/13/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Preliminary evaluation of the returned device indicates the swg/ars resistance - kinked.

Event Description

It was reported that the user felt a strong resistance when inserting swg (spring wire guide) through ars (syringe).The user felt as if the swg coiled up in the ars.A new kit was opened.

Event Description

It was reported that the user felt a strong resistance when inserting swg (spring wire guide) through ars (syringe).The user felt as if the swg coiled up in the ars.A new kit was opened.

Manufacturer Narrative

(b)(4).The customer returned a spring wire guide (swg) assembly, ars, and a catheter for evaluation.Signs of use in the form of biological material were present on the ars and swg.Visual inspection revealed the guidewire was kinked towards the distal end.The distal j-bend was slightly misshapen but both welds appeared full, spherical and intact.No defects or anomalies were observed on the ars.The kink in the guide wire measured 575 mm from the proximal tip.The overall length of the guide wire measured 602 mm which is within specification of 596-604 mm per swg product drawing.The outer diameter of the guide wire measured 0.793 mm which is within specification of 0.788-0.826 mm per product drawing.The returned guide wire was able to pass through the returned ars with minimal resistance.Resistance was only encountered at the kinked portion of the guidewire.The guide wire was also passed through the returned catheter and a lab inventory 18 ga introducer needle with minimal resistance.A manual tug test confirmed both the distal and proximal weld of the guide wire were intact.A device history record review was performed.A non-conformance was initiated for material snz-14703-002 ars syringe lot #71c19g1032 for burrs on the ars to further investigate this issue.However, this non-conformance is not relevant to this complaint as no burrs were detected on the returned ars.No other relevant findings were identified.The ifu provided with this kit includes the following warnings and cautions for the user: "do not cut guidewire to alter length." "do not withdraw guidewire against needle bevel to reduce risk of possible severing or damaging of guidewire." "do not use excessive force when introducing guidewire or tissue dilator as this can lead to vessel perforation and bleeding." "if resistance is encountered when attempting to remove guidewire after catheter placement, guidewire may be kinked about tip of catheter within vessel." "do not apply undue force on guidewire to reduce risk of possible breakage." "do not apply excessive force in removing guidewire or catheter.If withdrawal cannot be easily accomplished, a visual image should be obtained and further consultation requested." "do not cut guidewire with scalpel." "practitioners must be aware of the potential for entrapment of guidewire by any implanted device in circulatory system (i.E., vena cava filters, stents).Review patient's history before catheterization procedure to assess for possible implants.Care should be taken regarding length of guidewire inserted.It is recommended that if patient has a circulatory system implant, catheter procedure be done under direct visualization to minimize the risk of guidewire entrapment." the customer report of a damaged guide wire was confirmed by complaint investigation of the returned sample.The guide wire was kinked along its body.A device history record review was performed for the guidewire and the ars, with a potentially relevant finding related to burrs on the ars.However, the guidewire passed all relevant dimensional and functional testing.No defects were observed on the returned ars and the guidewire passed through the returned ars with minimal resistance.Based on the condition of the sample received, unintentional user error caused or contributed to this event.Teleflex will continue to monitor and trend for complaints of this nature.

• Brand Name: ARROW CVC SET: 2-LUMEN 7FR X 20CM
• Type of Device: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 10537929
• MDR Text Key: 207128971
• Report Number: 3006425876-2020-00838
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 09/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: JP-17702-C
• Device Lot Number: 71F19H0078
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/15/2020
• Date Manufacturer Received: 10/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1