MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. VASCULAR UNKNOWN DUMMY MATERIAL; ARROWG+ARD CATHETER PRODUCTS

Catalog Number VASCULAR UNKNOWN

Device Problems Material Separation (1562); Unraveled Material (1664); Physical Resistance (2578)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/09/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).No sample will be returned for evaluation.Med watch #mw5062849.

Event Description

Information was received via sus voluntary event report.The physician reported initial attempt to place catheter with ultrasound guidance without apparent complication.The wire advanced easily, tract was dilated, and the catheter advanced over the wire.Upon full advancement of the catheter the wire could not be withdrawn.The physician then withdrew the catheter 2cm and attempted to straighten the (b)(4) degree curve inherent to the design of the catheter.Upon withdrawal of the guidewire it was noted to be "unwinding" rather than truly coming out of the patient.With additional catheter manipulation the physician felt it "ease" and was comfortable the guidewire was actually coming out but then snapped.The distal port neither drew nor flushed though the proximal port did.A new guidewire was then used and advanced through the proximal port of the existing catheter.The physician felt position was correct.The catheter was withdrawn over this wire and a 15cm piece of the old wire was removed again with some initial resistance, though with repositioning of the "curve" it withdrew easily and completely.A chest x-ray shows appropriate positioning of both central venous catheters.There is, however, an approximately 4cm radiopaque strip at the cavo-atrial junction, suspicious for guidewire embolization.

• Brand Name: VASCULAR UNKNOWN DUMMY MATERIAL
• Type of Device: ARROWG+ARD CATHETER PRODUCTS
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• Manufacturer (Section G): ARROW INTERNATIONAL INC.; 312 commerce place; asheboro NC 27203
• Manufacturer Contact: jamie hartz ; 2400 bernville road; reading, PA 19605
• MDR Report Key: 5790604
• MDR Text Key: 49426147
• Report Number: 1036844-2016-00401
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K071538
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/07/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/13/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: VASCULAR UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/07/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1