MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW ARTERIAL CATH SET: 18 GA X 16CM; CATHETER PERCUTANEOUS

Model Number IPN920505

Device Problem Unraveled Material (1664)

Patient Problems Hematoma (1884); Hemorrhage/Bleeding (1888)

Event Date 03/19/2024

Event Type  malfunction  

Event Description

It was reported "catheter was inserted it was a dfficult insertion in femoral.The guide unravelled at removal.A new catheter was inserted, resulting in a haematoma at the puncture site and significant bleeding." the patient's current condition is "unknown" at this time.Additional information was requested, further information is unavailable at this time.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

Qn# (b)(4).The customer returned one guide wire for analysis.The catheter was not returned.The guide wire was unraveled and showed evidence of use.Visual examination revealed the guide wire was unraveled towards the distal end and had multiple kinks in the guide wire body.A portion of the core wire remained attached to the distal weld and was protruding out of the coil wire.The distal j-bend was misshapen but intact.Microscopic examination of the guide wire confirmed the distal weld was present at the end of the coil and core wire.The distal separation point of the core wire was tapered.Both welds appeared full and spherical.Visual inspection of the catheter could not be performed as the catheter was not returned.The major kinks in the guide wire body measured 3mm, 12mm, and 313mm from the proximal tip.The broken core wire segments measured 21 mm and 434 mm in length , with an overall length of 455 mm which is within the specification limits of 450-458 mm per guide wire product drawing; therefore, no pieces of the core wire appear to be missing.The outside diameter of the guide wire measured 0.610 mm which is within the specification limits of 0.610-0.635 mm per guide wire product drawing.Dimensional inspection of the catheter could not be performed as the catheter was not returned.Functional inspection of the guide wire could not be performed for this complaint investigation due to the damage to the returned guide wire.Functional inspection of the catheter could not be performed as the catheter was not returned.A manual tug test confirmed that both welds were intact.Additional testing of the catheter could not be performed as the catheter was not returned.A device history record review was performed on the guide wire and catheter and no relevant manufacturing issues were identified.The instructions-for-use (ifu) provided with this product warns the user, "precaution: use care when removing guidewire.If resistance is encountered, remove guidewire and catheter together as a unit.Use of excessive force may damage catheter or guidewire." the report that the guide wire was unraveled was confirmed through examination of the returned sample.The guide wire core wire was broken and unraveled towards the distal weld.The guide wire met all relevant dimensional requirements and a device history record review did not reveal any evidence of a manufacturing related issue.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 1.1 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 contributed to this event, however, the probable cause of guide wire and catheter resistance could not be determined based upon the information provided and without the catheter being returned for evaluation.Teleflex will continue to monitor and trend for reports of this nature.

Event Description

It was reported "catheter was inserted it was a dfficult insertion in femoral.The guide unravelled at removal.A new catheter was inserted, resulting in a haematoma at the puncture site and significant bleeding." the patient's current condition is "unknown" at this time.Additional information was requested, further information is unavailable at this time.

• Brand Name: ARROW ARTERIAL CATH SET: 18 GA X 16CM
• Type of Device: CATHETER PERCUTANEOUS
• Manufacturer (Section D): ARROW INTERNATIONAL LLC; morrisville NC
• Manufacturer (Section G): ARROW INTERNATIONAL CR, A.S.; jamska 2359/47; zdar nad sazavou 591 0 1; EZ 591 01
• Manufacturer Contact: keona jones ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 19071474
• MDR Text Key: 339894216
• Report Number: 3006425876-2024-00352
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K171146
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/09/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: IPN920505
• Device Catalogue Number: SAC-01618-PBX
• Device Lot Number: 71F24A1191
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/02/2024
• Date Manufacturer Received: 03/19/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/29/2024
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1