MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW CVC SET: 2-LUMEN 7FR X 60CM; CATHETER, PERCUTANEOUS

Catalog Number JP-17752-C

Device Problem Migration or Expulsion of Device (1395)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/23/2023

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that the catheter was inserted to the patient and fixed by the catheter clamp at 40cm from the tip of the catheter.As the patient had no body movement, the clamp was sutured with two stitches.Then, the catheter was found 'migrated" from the patient's body.Therefore, it was removed and replaced with a new one.No injury to the patient was reported.When the migration occurred, the catheter clamp had moved 5cm from the tip of the catheter.It was reported the physician noticed that the catheter migrated from the patient's body when attempting to remove it.The catheter was expelled completely from the patient's body.The catheter had been inserted in the femoral vein.

Event Description

It was reported that the catheter was inserted to the patient and fixed by the catheter clamp at 40cm from the tip of the catheter.As the patient had no body movement, the clamp was sutured with two stitches.Then, the catheter was found migrated from the patient's body.Therefore, it was removed and replaced with a new one.No injury to the patient was reported.When the migration occurred, the catheter clamp had moved 5cm from the tip of the catheter.It was reported the physician noticed that the catheter migrated from the patient's body when attempting to remove it.The catheter was expelled completely from the patient's body.The catheter had been inserted in the femoral vein.

Manufacturer Narrative

Qn#(b)(4).The customer returned one 2-l cvc for analysis.Signs of use in the form of biological material was observed on the catheter body.The clamp catheter and fastener were returned attached to the catheter body.Visual analysis of the catheter revealed that the box clamp was returned attached to the catheter body.Visual analysis of the returned catheter, clamp fastener, and the clamp catheter did not reveal any defects or anomalies.There is no evidence to suggest that the catheter suture wings (on juncture hub) were ever secured with sutures.The catheter length measured 625mm, which is within the specifications of 612-632mm per product drawing.The catheter outer diameter measured 2.42mm, which is within the specifications of 2.36-2.46mm per product drawing.The clamp catheter inner diameter measured 0.089", which is within the specifications of 0.088"-0.092" per product drawing.Functional inspection was performed per the instructions for use (ifu) provided with the kit which states, "use a catheter stabilization device , catheter clamp and fastener, staples or sutures (where provided).Use catheter hub as primary securement site.Use catheter clamp and fastener as a secondary securement site as necessary".The catheter clamp and fastener were attached to the returned catheter body.The box clamp assembly was held stationary, and the catheter was pulled in both directions.Slight movement was identified.The suture wings of the juncture hubs were then held stationary, and the catheter was pulled in both directions.No movement was identified.A device history record review was performed, and no relevant findings were identified.The ifu provided with the kit informs the user, "use a catheter stabilization device, catheter clamp and fastener, staples or sutures (where provided).Use catheter hub as primary securement site.Use catheter clamp and fastener as a secondary securement site as necessary".The customer report of a catheter migration was confirmed by functional testing of the returned sample.The catheter moved slightly when secured by only the box clamp but passed testing when secured by the juncture hub suture wings.The primary suture location for this catheter is the juncture hub using the triangular wings.It could not be determined if the box clamp was used as the primary or secondary suture site; therefore, the probable cause could not be determined.Teleflex will continue to monitor and trend for complaints of this nature.

• Brand Name: ARROW CVC SET: 2-LUMEN 7FR X 60CM
• 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: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 16405422
• MDR Text Key: 309871932
• Report Number: 3006425876-2023-00143
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 01/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/20/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: JP-17752-C
• Device Lot Number: 71F22B0651
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/06/2023
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/13/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/11/2022
• 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