MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC CVC SET: 3-LUMEN 7FR X 20CM; CATHETER, PERCUTANEOUS

Model Number IPN926838

Device Problem Unraveled Material (1664)

Patient Problem Insufficient Information (4580)

Event Date 12/15/2023

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that "swg unravelled during removal".Additional information: the device was removed in its entirety.There was no reported patient harm or consequence.

Event Description

It was reported that "swg unravelled during removal".Additional information: the device was removed in its entirety.There was no reported patient harm or consequence.

Manufacturer Narrative

(b)(4).The report that the guide wire unravelled was confirmed through examination of the returned sample.The customer returned an opened cvc kit including a guide wire and a 3-lumen catheter for evaluation.The guide wire was advanced through the catheter and was unravelled.The components showed evidence of use in the form of dried blood.Visual examination revealed the guide wire was unravelled from the proximal weld and has one kink along the body.The returned catheter showed evidence of use but no obvious defects or anomalies.Microscopic examination of the guide wire confirmed the core wire was broken adjacent to the proximal weld.The exposed proximal core wire tip was tapered and discoloured at the point of separation.Both welds were present and appeared full and spherical.Microscopic examination of the catheter did not reveal any defects or anomalies.The kink in the guide wire body measured 390 mm via calibrated ruler from the distal tip.The broken core wire measured 602 mm in length via calibrated ruler, which was within the specification of 596-604 mm per guide wire product drawing; therefore, no pieces of the core wire appear to be missing.The outside diameter (od) of the guide wire measured 0.803 mm via calibrated micrometer which was within the od specification of 0.788-0.826 mm per guide wire product drawing.Functional testing could not be performed due to the nature of the damage on the guide wire.A manual tug test confirmed that the distal weld was intact.The instructions-for-use (ifu) provided with this product describes suggested techniques to minimize the likelihood of guide wire damage during use.The ifu cautions that 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.A device history record review was performed, and no relevant manufacturing issues were identified.Arrow guide wires of this size are designed and manufactured to withstand a tensile force of 2.75 pounds force.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.

• Brand Name: CVC SET: 3-LUMEN 7FR X 20CM
• 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: 18473790
• MDR Text Key: 332381291
• Report Number: 3006425876-2024-00051
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: IPN926838
• Device Catalogue Number: EU-15703-CVT
• Device Lot Number: 71F22K2785
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/28/2023
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/09/2024
• Supplement Dates Manufacturer Received: 01/30/2024
• Supplement Dates FDA Received: 02/01/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/03/2022
• 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