MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW EXT DWELL CATH DEVICE 20GAX6CM; CATHETER INTRAVASCULAR THERAPE

Catalog Number EDC-00620

Device Problems Detachment of Device or Device Component (2907); Material Integrity Problem (2978); Migration (4003)

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

Event Date 06/04/2020

Event Type  Injury  

Manufacturer Narrative

Qn# (b)(4).Response to additional questions from risk management: was there harm or is the patient fine? pt discharged.Rx anti- coagulants.Keeping watch.What is the patient's current condition? good.Was therapy delayed/interrupted? no.Any medical intervention was required.No.Pt is (b)(6) and is on blood thinners currently.Any concerns about possible migration of the missing catheter tip? perhaps into the lungs - pe is a concern.

Event Description

The customer reported: upon catheter removal it was then noted that the catheter tip was rough and missing approximately 0.5 to 1 cm.Cephalic intra-vascular catheter foreign body with migration.Cath tip was not recovered.

Manufacturer Narrative

(b)(4).The actual device was not returned; however, the customer provided one photo for evaluation.The photo displayed two endurance catheters: one contained no damage and one appeared to have a sheared tip.Evidence of use was observed on the body of the damaged catheter.However, a full 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 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 customer report of a separated catheter tip was confirmed by visual examination of the customer supplied photo.The image shows an endurance catheter with evidence of use and a sheared tip.However, root cause 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 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 reported: upon catheter removal it was then noted that the catheter tip was rough and missing approximately 0.5 to 1cm.Cephalic intra-vascular.Catheter foreign body with migration.Cath tip was not recovered.

• Brand Name: ARROW EXT DWELL CATH DEVICE 20GAX6CM
• Type of Device: CATHETER INTRAVASCULAR THERAPE
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 10148530
• MDR Text Key: 194964746
• Report Number: 9680794-2020-00276
• 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: 06/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/12/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 11/30/2020
• Device Catalogue Number: EDC-00620
• Device Lot Number: 14F18K0242
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 80 YR