MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW ARTERIAL CATH SET: 18GA X 12CM; CATHETER, PERCUTANEOUS

Catalog Number SAC-01218

Device Problem Device Damaged Prior to Use (2284)

Patient Problem Insufficient Information (4580)

Event Date 08/09/2023

Event Type  malfunction  

Manufacturer Narrative

Qn # (b)(4).

Event Description

It was reported that: product damaged inside the box.Additional information: the box was not damaged but the product was damaged in the box.Photo shows a kinked guide wire.Associated to 3006425876-2023-00849.

Event Description

It was reported that: product damaged inside the box.Additional information: the box was not damaged but the product was damaged in the box.Photo shows a kinked guide wire.Associated to 3006425876-2023-00849.

Manufacturer Narrative

(b)(4).The customer report of a kinked guide wire was confirmed through complaint investigation of the returned sample.The customer provided one photo for analysis and returned one unopened sac set for evaluation.The photo shows the kinked guide wire within the protective tubing inside the packaging.The returned packaging had one major crease that aligns with the kink in the guide wire and protective tubing.The kit was opened to better analyze the components.The protective tubing had one kink towards the distal end.The protective tubing was removed to reveal the guide wire was also kinked.The lid stock clearly states, "do not bend." the damage observed was consistent with defects related to storage and shipping.Microscopic examination confirmed the damage and revealed that the distal and proximal welds were secure and intact.No other defects or anomalies were observed.The kink on the guide wire measured 24mm from the distal tip.The guide wire length measured 338mm, which was within the specification limits of 331mm-340mm per the guide w ire product drawing.Both the kink and the guidewire length were measured via calibrated ruler.The guide wire outer diameter (od) measured 0.616mm via calibrated micrometer, which was within the specification limits of 0.61mm-0.64mm per the guide wire product dra wing.Functional inspection was performed per ifu statement, "thread tip of indwelling catheter over spring-wire guide.Precaution: allow sufficient guide wire length to remain exposed at hub end of catheter to maintain firm grip on guide wire.Grasping near skin, advance catheter into vessel with slight twisting motion." the guide wire was advanced through the returned catheter, and it was able to pass with little resistance.A manual tug test confirmed that the distal and proximal welds were intact.The instructions for use (ifu) provided with this kit warns the user, "do not use if package has been previously opened or damaged." the product labelling was updated to clearly inform the customer to not bend the product and was intended to reduce the potential for product damage.A device history record review was performed, and no relevant findings were identified.Based on the customer description and the sample received, storage and shipping caused or contributed to this event.Teleflex will continue to monitor and trend for reports of this nature.

• Brand Name: ARROW ARTERIAL CATH SET: 18GA X 12CM
• 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: kevin don bosco ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 17554421
• MDR Text Key: 321230228
• Report Number: 3006425876-2023-00852
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K093050
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/16/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: SAC-01218
• Device Lot Number: 71F21F0965
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/14/2023
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/04/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/15/2021
• 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
• Treatment: NOT REPORTED.; NOT REPORTED.