MAUDE Adverse Event Report: TELEFLEX MEDICAL VASCULAR UNKNOWN DUMMY MATERIAL

Catalog Number VASCULAR UNKNOWN

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Extravasation (1842); No Known Impact Or Consequence To Patient (2692)

Event Date 12/22/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).The device is not being returned investigation.Teleflex will continue to monitor and trend related events.

Event Description

Per article: a (b)(6) female presented to the emergency department after a traumatic fall with symptoms of an acute stroke.Iv access failed and humeral io access was obtained using the ezio device and placement confirmed (no size of needle indicated).Contrast media was injected at 3.5 ml/sec and during scan an extravasation of approximately 20 ml of contrast was noted within the gleno-humeral joint.The patient denied post procedural pain, and physical exam failed to reveal a neurological or vascular deficit, either immediately after the scan, the following day or one-week post-procedure.The exact cause of the extravasation was unknown with possible causes being 1) the humeral io needle can pass through the subdeltoid bursa during placement.Contrast passing retrograde along the ion tract could then enter the joint space via its connection to the bursa 2) a change in orientation of the driver during placement may have widened the needle tract 3) contrast passed directly into the joint space through an interruption in the periarticular bone.

• Brand Name: VASCULAR UNKNOWN DUMMY MATERIAL
• Manufacturer (Section D): TELEFLEX MEDICAL; athlone
• Manufacturer (Section G): ARROW INTERNATIONAL INC.; 312 commerce place; asheboro NC 27203
• Manufacturer Contact: effie jefferson ; 3015 carrington mill blvd; morrisville 27560 ; 9194332672
• MDR Report Key: 7695021
• MDR Text Key: 114214917
• Report Number: 1036844-2018-00192
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: VASCULAR UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/21/2018
• Initial Date FDA Received: 07/17/2018
• 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: N
• Patient Sequence Number: 1
• Patient Age: 66 YR