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

Catalog Number CV-15703

Device Problems Material Frayed (1262); Unraveled Material (1664)

Patient Problems No Known Impact Or Consequence To Patient (2692); Device Embedded In Tissue or Plaque (3165); No Information (3190)

Event Date 09/09/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

The customer reports: performing the procedure to catheterize the left subclavian vein, it is performed without complications in a single attempt, then the guide is passed without problems and when dilated with the catheter dilator it is evident that the guide begins to unwind and fray.The procedure is completely suspended, and the device is stuck without being able to remove it from the vein.It is necessary to refer to vascular surgery to remove the device.Device removed in its entirety.

Manufacturer Narrative

Qn#(b)(4).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.If the sample becomes available at a later date a follow up report will be submitted with investigation results.

Event Description

The customer reports: performing the procedure to catheterize the left subclavian vein, it is performed without complications in a single attempt, then the guide is passed without problems and when dilated with the catheter dilator it is evident that the guide begins to unwind and fray.The procedure is completely suspended, and the device is stuck without being able to remove it from the vein.It is necessary to refer to vascular surgery to remove the device.Device removed in its entirety.

• Brand Name: ARROW CVC SET: 3-LUMEN 7 FR X 20 CM
• Type of Device: CATHETER PERCUTANEOUS
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 9172218
• MDR Text Key: 161711821
• Report Number: 9680794-2019-00368
• 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,health pr
• Type of Report: Initial,Followup
• Report Date: 09/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/09/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2022
• Device Catalogue Number: CV-15703
• Device Lot Number: 14F17H0293
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/30/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention