MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW VESSEL CATH SET: 24 GA X 9CM; CATHETER, PERCUTANEOUS

Model Number IPN031491

Device Problems Unraveled Material (1664); Physical Resistance/Sticking (4012)

Patient Problems No Consequences Or Impact To Patient (2199); Blood Loss (2597)

Event Date 08/18/2020

Event Type  Injury  

Manufacturer Narrative

Qn#: (b)(4).Additional customer information: "the patient is fine, in good health.Finally, the picc line was not inserted, another catheter was inserted in left jugular.".

Event Description

It was reported that: patient is a child.During the insertion of the catheter in jugular, there was a blockage of the needle while the needle was advancing through the guide.The needle and the guide got stuck.The staff had to use force to remove the guide.When the guide came out it was unraveled, as if there was the use of a force.Please note, no sudden movement was made, the child did not make any move neither.The needle had been tested and was advancing in the guide at test before the intervention started.Additional information: the correct blockage was "a blockage of the needle when the guide was advancing through the needle." clinical consequences: venous dissection with significant bleeding at the puncture site.Inability to insert the catheter.Child was sent to surgery room for insertion of a picc-line.

Manufacturer Narrative

(b)(4).The customer returned one guide wire and product lidstock for evaluation.The introducer needle was not returned for investigation.Visual inspection of the guide wire revealed one prominent bend near the center of the guide wire.The distal j-tip also contained numerous kinks, bends, and offset coils.Visual examination of the introducer needle could not be performed as it was not returned for analysis.The guide wire contained one prominent bend 235 mm from the proximal end.The guide wire also contained kinks, bends, and offset coils from 325-350 mm from the proximal weld.The total length of the guide wire measured to be 350 mm which is within specifications of 350-355.6 mm per product drawing.The outer diameter of the returned guide wire measured to be 0.443 mm which is within specifications of 0.432-0.457 mm per product drawing.The returned guide wire was able to pass through a lab inventory introducer needle with significant resistance encountered at the kinks/bends.A manual tug test of the guide wire confirmed both welds were fully intact.A device history record review was performed 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/needle resistance could not be confirmed by complaint investigation without the needle to evaluate.The guide wire passed all relevant dimensional testing and a device history record review was performed with no relevant findings.The probable root cause could not be determined based on the information provided and without the introducer needle to evaluate.Teleflex will continue to monitor and trend for complaints of this nature.

Event Description

It was reported that: patient is a child.During the insertion of the catheter in jugular, there was a blockage of the needle while the needle was advancing through the guide.The needle and the guide got stuck.The staff had to use force to remove the guide.When the guide came out it was unraveled, as if there was the use of a force.Please note, no sudden movement was made, the child did not make any move neither.The needle had been tested and was advancing in the guide at test before the intervention started.Additional information: the correct blockage was "a blockage of the needle when the guide was advancing through the needle." clinical consequences: venous dissection with significant bleeding at the puncture site.Inability to insert the catheter.Child was sent to surgery room for insertion of a picc-line.

• Brand Name: ARROW VESSEL CATH SET: 24 GA X 9CM
• Type of Device: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 10453482
• MDR Text Key: 204354009
• Report Number: 3006425876-2020-00761
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• PMA/PMN Number: K810962
• 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: 08/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2023
• Device Model Number: IPN031491
• Device Catalogue Number: ES-04650
• Device Lot Number: 71F18L1538
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/27/2020
• Initial Date Manufacturer Received: 08/18/2020
• Initial Date FDA Received: 08/26/2020
• Supplement Dates Manufacturer Received: 09/03/2020
• Supplement Dates FDA Received: 09/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention