MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW CVC SET: 3-LUMEN 4FR X 13CM; CATHETER, PERCUTANEOUS

Catalog Number SA-14403

Device Problem Device Damaged by Another Device (2915)

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

Event Date 02/09/2021

Event Type  malfunction  

Manufacturer Narrative

Qn#: (b)(4).

Event Description

The complaint is reported as: guidewire went through the lumen piercing the catheter wall causing leakage during insertion.Three catheters used on the same patient experienced this issue.The first catheter was inserted in the right femoral, the second catheter inserted in the left femoral, and the third catheter was inserted in the right subclavian.A fourth catheter was successfully placed in the right subclavian.No patient injury reported during or after catheter placement.The patient's condition is reported as fine.

Event Description

The complaint is reported as: guidewire went through the lumen piercing the catheter wall causing leakage during insertion.Three catheters used on the same patient experienced this issue.The first catheter was inserted in the right femoral, the second catheter inserted in the left femoral, and the third catheter was inserted in the right subclavian.A fourth catheter was successfully placed in the right subclavian.No patient injury reported during or after catheter placement.The patient's condition is reported as fine.

Manufacturer Narrative

Qn#(b)(4).The actual sample was not returned; however, the customer provided one photo for analysis.The complaint of a catheter body cut/torn was not able to be confirmed by the photo.A complete visual inspection could not be performed as no sample was returned for analysis.A device history record review was performed, and no relevant findings were identified.The instructions for use (ifu) provided with this kit warns the user, "do not apply excessive force in removing guide wire or catheters.If withdrawal cannot be easily accomplished, a chest x-ray should be obtained and further consultation requested.Do not suture directly to outside diameter of catheter to minimize the risk of cutting or damaging the catheter or impeding catheter flow".The complaint could not be confirmed by the customer's returned photo.Complaint verification testing could not be performed as no sample was returned for analysis.A device history record review was performed and no relevant findings were identified.Without the device to evaluate, the complaint could not be confirmed and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.

• Brand Name: ARROW CVC SET: 3-LUMEN 4FR X 13CM
• Type of Device: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 11399099
• MDR Text Key: 234258280
• Report Number: 3006425876-2021-00174
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• 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: 02/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/02/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/29/2024
• Device Catalogue Number: SA-14403
• Device Lot Number: 71F19E1522
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 03/30/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 6 WK