MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW EXT DWELL CATH DEVICE 20GAX8CM; CATHETER INTRAVASCULAR THERAP

Catalog Number EDC-00818

Device Problems Cut In Material (2454); Physical Resistance (2578)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/24/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The customer reports: clinician inserted the catheter under ultrasound on patient's left arm and it looked to be in the vessel.Resistance was met when trying to advance the catheter over the needle and when the whole device was pulled out of the patient, the catheter was stuck and could not be easily pulled out.When the device finally did come out, the catheter was sheared at the tip about 1cm proximal.The wire was intact so there was no concern of anything left in the patient.A new device and successfully placed in the patient's right arm.There was no patient injury or consequence.The patient's condition is reported as "fine.Therapy was reported to be delayed/interrupted.

Manufacturer Narrative

(b)(4).Corrected data: lot# corrected to 14f17f0248.Catalog# corrected to edc-00818.Expiration date corrected to 06/30/2019.Device manufacture date corrected to 07/2017.The customer returned one catheter assembly for evaluation.The returned catheter contained signs of use in the form of biological material.Visual examination revealed one hole in the catheter near the distal end.The hole was jagged and contained white coloration, indicative that the needle bevel punctured the catheter.The catheter contained one hole 7mm from the distal tip.The length of the catheter body measured to be 3.54" which is within specification.A device history record review was performed with no relevant findings.The instructions for use (ifu) provided with this kit cautions the user, "do not attempt to advance needle back into catheter after catheter is partially threaded off needle to reduce risk of catheter damage." the reported complaint of a sheared catheter tip was confirmed by complaint investigation.The returned catheter contained one hole near the distal tip.The hole contained jagged edges and white coloration, indicating contact with sharps.The catheter passed all relevant dimensional testing.A device history record review was performed with no relevant findings.Based on the sample received, it was determined that operational context caused or contributed to this event.

Event Description

The customer reports: clinician inserted the catheter under ultrasound on patient's left arm and it looked to be in the vessel.Resistance was met when trying to advance the catheter over the needle and when the whole device was pulled out of the patient, the catheter was stuck and could not be easily pulled out.When the device finally did come out, the catheter was sheared at the tip about 1cm proximal.The wire was intact so there was no concern of anything left in the patient.A new device and successfully placed in in the patient's right arm.There was no patient injury or consequence.The patient's condition is reported as "fine.Therapy was reported to be delayed/interrupted.

• Brand Name: ARROW EXT DWELL CATH DEVICE 20GAX8CM
• Type of Device: CATHETER INTRAVASCULAR THERAP
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 7247801
• MDR Text Key: 99243420
• Report Number: 9680794-2018-00027
• 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: 01/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/07/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2019
• Device Catalogue Number: EDC-00818
• Device Lot Number: 14F17F0248
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/31/2018
• Date Manufacturer Received: 03/12/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1