MAUDE Adverse Event Report: ARROW INTERNAL INC. ARROW; VASCULAR POSITIONING WIRE SENSOR

Lot Number 73A160293

Device Problem Uncoiled (1659)

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

Event Date 03/17/2016

Event Type  malfunction  

Event Description

Doppler wire came uncoiled after removing from pt during ficc insertion.

• Brand Name: ARROW
• Type of Device: VASCULAR POSITIONING WIRE SENSOR
• Manufacturer (Section D): ARROW INTERNAL INC.; 2400 bernville road; reading PA 19605
• MDR Report Key: 5516097
• MDR Text Key: 40950171
• Report Number: MW5061043
• Device Sequence Number: 1
• Product Code: LJS
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/18/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/18/2018
• Device Lot Number: 73A160293
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/21/2016
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 80 YR
• Patient Weight: 74