MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW EXT DWELL CATH DEVICE 18GAX8CM; CATHETER INTRAVASCULAR THERAPE

Catalog Number EDC-00818

Device Problem Material Split, Cut or Torn (4008)

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

Event Date 07/08/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The customer reports: while the device was in the subcutaneous tissue, the catheter sheared, leaving a piece of the catheter in the patient's tissue.Surgery was consulted and they removed the piece of catheter.

Manufacturer Narrative

Qn# (b)(4).The report that the catheter separation was confirmed through examination of the customer supplied photos.The images show the catheter body separated about halfway down the catheter body; however, the actual complaint sample was not returned for evaluation.The device history records for the catheter were reviewed with no evidence to suggest a manufacturing related cause.The probable cause of the catheter separation could not be determined based upon the information provided and without the actual complaint sample returned for evaluation.The ifu provided with this kit warns the user "do not force catheter if resistance is encountered during advancement." the ifu also contains a warning related to device prep/setup "prior to insertion, distal tip of catheter must be fully retracted past needle bevel or catheter tip damage may occur." other remarks: corrective action is not required at this time as the probable cause could not be determined based upon the information provided and without a sample returned for evaluation.Teleflex will continue to monitor and trend for reports of this nature.

Event Description

The customer reports: while the device was in the subcutaneous tissue, the catheter sheared, leaving a piece of the catheter in the patient's tissue.Surgery was consulted and they removed the piece of catheter.

• Brand Name: ARROW EXT DWELL CATH DEVICE 18GAX8CM
• Type of Device: CATHETER INTRAVASCULAR THERAPE
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 8816870
• MDR Text Key: 151888023
• Report Number: 9680794-2019-00262
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• PMA/PMN Number: K151513
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 07/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/23/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2021
• Device Catalogue Number: EDC-00818
• Device Lot Number: 14F19C0288
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/25/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention