MAUDE Adverse Event Report: GYRUS ACMI, INC ULTRA-CATCH NT (1.8 FR X 115 CM) STONE RETRIEVAL DEVICE

Model Number NT4W18115

Device Problem Component Falling (1105)

Patient Problem No Code Available (3191)

Event Type  malfunction  

Manufacturer Narrative

At the time of this report, the device has not yet been returned for evaluation.As a result, a determination cannot be made at this time.If further information becomes available, gyrus acmi will continue the investigation and update the agency accordingly.

Event Description

The basket of nt4w18115 stone retrieval device has fallen in the kidney of the patient and had to be recovered.The hospital has recovered the basket.

Manufacturer Narrative

Weld site failures between the core wire and basket connector tube due to excessive force applied to the basket during use.

• Brand Name: ULTRA-CATCH NT (1.8 FR X 115 CM) STONE RETRIEVAL DEVICE
• Type of Device: STONE RETRIEVAL DEVICE
• Manufacturer (Section D): GYRUS ACMI, INC; 136 turnpike road; southborough MA 01772
• Manufacturer Contact: terrence sullivan ; 136 turnpike road; southborough, MA 01772 ; 508804-273
• MDR Report Key: 6609276
• MDR Text Key: 76724894
• Report Number: 3011050570-2017-00002
• Device Sequence Number: 1
• Product Code: FGO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PEXEMPT-FGO
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/03/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/02/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: NT4W18115
• Device Lot Number: MK643255
• Other Device ID Number: UDI
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/28/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention