MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW CVC SET: 2-LUMEN 7 FR X 20 CM; CATHETER PERCUTANEOUS

Catalog Number CV-17702-BZ

Device Problems Difficult to Advance (2920); Material Deformation (2976); Material Twisted/Bent (2981)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Information (3190)

Event Date 01/14/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).It is unknown if the device is available for evaluation.

Event Description

The customer reports: the tip of the guide wire bends, making it difficult to pass the catheter, which can cause loss of access and expenditure on material.

Manufacturer Narrative

Qn#(b)(4).Complaint verification testing could not be performed as it was reported that the sample is not available for return.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.

Event Description

The customer reports: the tip of the guide wire bends, making it difficult to pass the catheter, which can cause loss of access and expenditure on material.

• Brand Name: ARROW CVC SET: 2-LUMEN 7 FR X 20 CM
• Type of Device: CATHETER PERCUTANEOUS
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 10051844
• MDR Text Key: 190791637
• Report Number: 9680794-2020-00240
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• PMA/PMN Number: K862056
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,other
• Type of Report: Initial,Followup
• Report Date: 04/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/13/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 06/30/2023
• Device Catalogue Number: CV-17702-BZ
• Device Lot Number: 14F18F0451
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1