L-CLIP APPL/REMVR 90 MM RND HANDLE VAR 45.441_EV

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 99 report with the FDA on 2013-12-18 for L-CLIP APPL/REMVR 90 MM RND HANDLE VAR 45.441_EV manufactured by Peter Lazic Gmbh.

Event Text Entries

[4891924] Report received from the usa stating that during an aneurysm clipping procedure, the device would not release the aneurysm clip. The vessel was ruptured and the pt is recovery. There was no add'l info provided.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 1045834-2013-15520
• MDR Report Key: 3994543
• Report Source: 99
• Date Received: 2013-12-18
• Date of Report: 2012-07-06
• Date of Event: 2012-06-26
• Date Facility Aware: 2012-07-06
• Report Date: 2012-07-06
• Date Reported to Mfgr: 2012-07-06
• Date Added to Maude: 2014-08-11
• Event Key: 0
• Report Source Code: Distributor report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Manufacturer Street: 4500 RIVERSIDE DR.
• Manufacturer City: PALM BEACH GARDENS FL 33410
• Manufacturer Country: US
• Manufacturer Postal: 33410
• Manufacturer G1: THE ANSPACH EFFORT, INC.
• Manufacturer Street: 4500 RIVERSIDE DR.
• Manufacturer City: PALM BEACH GARDENS FL 33410
• Manufacturer Country: US
• Manufacturer Postal Code: 33410
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: L-CLIP APPL/REMVR 90 MM RND HANDLE VAR
• Generic Name: NONE
• Product Code: HCI
• Date Received: 2013-12-18
• Catalog Number: 45.441_EV
• Device Age: DA
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: PETER LAZIC GMBH
• Manufacturer Address: TUTTLINGEN GM

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Hospitalization; 2. Required No Informationntervention	2013-12-18