MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW CVC SET: 3-LUMEN 12 FR X 20 CM; CATHETER, INTRAVASCULAR, THERAPEUTIC

Catalog Number CS-25123-F

Device Problem Material Separation (1562)

Patient Problems No Known Impact Or Consequence To Patient (2692); Device Embedded In Tissue or Plaque (3165); No Information (3190)

Event Date 09/17/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).No additional information provided by the user facility at the time of this report.

Event Description

It was reported that according to the doctor the guidewire broke off in patient.No report of an intervention required.

Event Description

It was reported that according to the doctor the guidewire broke off in patient.No report of an intervention required.

Manufacturer Narrative

Qn#(b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.A device history record review was performed and no relevant findings were identified.Without the device to evaluate the complaint could not be confirmed and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.If the sample becomes available at a later date a follow up report will be submitted with investigation results.

Manufacturer Narrative

Qn#: (b)(4).The customer returned a severely unraveled and tangled guide wire for analysis.After untangling the guide wire, it was discovered that a portion of the coil wire near the distal end had separated from the rest of the assembly.Despite this separation, the distal weld was secure to the separated portion of the coil wire.The proximal weld appeared secure and intact.Microscopic examination confirmed that the core wire was broken directly adjacent to the distal weld.No other defects or anomalies were observed.The total guide wire length from the proximal weld to the point of separation on the core wire measured 682mm, which is within the specification limits of 678mm-688mm per the guide wire graphic.The guide wire outer diameter measured.848mm, which is within the specification limits of.838mm-.877mm per the guide wire graphic.Functional testing could not be performed due to the damage to the guide wire.A manual tug test confirmed that the proximal weld was secure and intact.A device history record review was performed, and no relevant findings were identified.The ifu provided with the kit informs the user, "do not withdraw spring-wire guide against needle bevel to minimize the risk of possible severing or damaging of spring-wire guide".The ifu also states, "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 wire." the report that the guide wire separated was confirmed through complaint examination of the returned sample.Visual analysis revealed that the coil wire had separated towards the distal end.Additionally, the core wire was broken adjacent to the distal weld.The guide wire met all relevant dimensional requirements, and a device history record review did not reveal any relevant findings.Arrow guide wires of this size are designed and manufactured to withstand a tensile force of 2.75 pounds force.The 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 caused or contributed to this event.Teleflex will continue to monitor and trend for reports of this nature.

Event Description

It was reported that according to the doctor the guidewire broke off in patient.No report of an intervention required.

• Brand Name: ARROW CVC SET: 3-LUMEN 12 FR X 20 CM
• Type of Device: CATHETER, INTRAVASCULAR, THERAPEUTIC
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 9162803
• MDR Text Key: 161432703
• Report Number: 3006425876-2019-00751
• Device Sequence Number: 1
• Product Code: FOZ
• 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,Followup
• Report Date: 09/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/07/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/05/2020
• Device Catalogue Number: CS-25123-F
• Device Lot Number: 71F18L2487
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/09/2020
• Date Manufacturer Received: 03/31/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1