MAUDE Adverse Event Report: OSTA ULTRA-CATCH NT (1.8 FR X 115 CM) STONE RETRIEVAL DEVICE

Model Number NT4W18115

Device Problems Device Inoperable (1663); Torn Material (3024)

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

Event Date 05/19/2016

Event Type  malfunction  

Event Description

Lot mk915806 wire is torn.The basket couldn't be operated any more with the grip.

• Brand Name: ULTRA-CATCH NT (1.8 FR X 115 CM) STONE RETRIEVAL DEVICE
• Manufacturer (Section D): OSTA; 136 turnpike road; southborough 01772
• Manufacturer Contact: terrence sullivan ; 136 turnpike road; southborough, MA 01772 ; 508804-273
• MDR Report Key: 5694401
• MDR Text Key: 47593035
• Report Number: 3003790304-2016-00003
• Device Sequence Number: 1
• Product Code: FGO
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: PEXEMPT-FGO
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/02/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/02/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: NT4W18115
• Other Device ID Number: UDI
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/23/2016
• 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