MAUDE Adverse Event Report: GYRUS ACMI, INC. AMPLATZ PTFE; STYLET, URETERAL

Catalog Number REF # 13

Device Problem Unraveled Material (1664)

Patient Problem No Information (3190)

Event Date 09/17/2018

Event Type  No Answer Provided  

Event Description

When using wire and attempting to remove, the wire unraveled.

• Brand Name: AMPLATZ PTFE
• Type of Device: STYLET, URETERAL
• Manufacturer (Section D): GYRUS ACMI, INC.; 136 turnpike rd; southborough MA 01772
• MDR Report Key: 7933367
• MDR Text Key: 122670595
• Report Number: 7933367
• Device Sequence Number: 1
• Product Code: EYA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 09/28/2018,09/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/04/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: REF # 13
• Device Lot Number: 11021391
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/28/2018
• Event Location: Hospital
• Date Report to Manufacturer: 10/04/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1