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

Catalog Number CS-25123-F

Device Problem Material Deformation (2976)

Patient Problem Death (1802)

Event Date 12/07/2019

Event Type  Death  

Manufacturer Narrative

(b)(4).The patient is deceased.Cause of death is currently unknown.Additional information requested regarding this event.No additional information received at the time of this report.

Event Description

The customer reports that the doctor inserted the guidewire through the dilator and exerted some pressure on the dilator and the guidewire kinked.

Manufacturer Narrative

Qn#(b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.A device history record review could not be performed as no lot number was provided by the customer and a potential lot could not be identified from a sales history review for this finished good.The instructions-for-use provided with this kit warns 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 wire." the ifu also cautions the user "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." 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.

Event Description

The customer reports that the doctor inserted the guidewire through the dilator and exerted some pressure on the dilator and the guidewire kinked.

Manufacturer Narrative

Qn#(b)(4).Corrected data: mfr.Report # -please correct mdr# to 3006425876-2020-00415.Section d.3.-manufacturer name corrected to arrow international inc., reading, pa.Section d.4.-catalog# corrected to cs-25123-f.Section d.4.-lot# identified as 71f19c2232.Section g.9.-please correct mdr# to 3006425876-2020-00415.Note: the initial and follow-up reports were submitted under mdr#9680794-2020-00044; however, the correct mdr# should be 300642587 6-2020-00415 as the product code has changed, thus the manufacturing facility (registration #) has changed as well.Please update mdr# in maude database system.The customer returned one guide wire assembly and lidstock for evaluation.The dilator was not returned for evaluation.The guide wire contained significant signs of use in the form of biological material.Visual examination of the wire revealed one prominent kinked area.Both the proximal and distal welds appeared fully spherical and intact.The kinked/damaged portion of the guide wire measured 445-458 mm from the proximal end of the guide wire.The total length of the guide wire measured to be 680 mm which is within specifications of 678-688 mm per product drawing.The outer diameter of the guide wire measured to be 0.844 mm which is within specifications of 0.838-0.877 mm per product drawing.The returned guide wire was able to pass through a lab inventory dilator with slight resistance encountered at the kinks.A manual tug test confirmed the distal and proximal welds were fully intact.A device history record review was performed on the guide wire and dilator with no relevant findings.The instructions-for-use provided with this kit warns 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 wire." the customer report of guide wire/dilator resistance was not confirmed by complaint investigation as the dilator was not returned for evaluation.The returned guide wire contained one prominent kinked area, which indicates undue force caused the damage.The sample passed all relevant dimensional and functional testing, and a device history record review was performed with no relevant findings.Although this damage indicates undue force likely caused the defect, the probable root cause could not be determined without the dilator returned to evaluate.Teleflex will continue to monitor and trend for complaints of this nature.

Event Description

The customer reports that the doctor inserted the guidewire through the dilator and exerted some pressure on the dilator and the guidewire kinked.

• Brand Name: ARROW CVC KIT: 3-LUMEN 12 FR X 20 CM
• Type of Device: CATHETER INTRAVASCULAR THERAPE
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 9580967
• MDR Text Key: 174700814
• Report Number: 9680794-2020-00044
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• PMA/PMN Number: K900263
• 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: 12/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/13/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/01/2021
• Device Catalogue Number: CS-25123-F
• Device Lot Number: 71F19C2232
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/09/2020
• Date Manufacturer Received: 04/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 41 YR