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

Model Number NT4W18115

Device Problems Difficult to Remove (1528); Sticking (1597)

Patient Problem No Code Available (3191)

Event Date 11/19/2015

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

Gyrus acmi was informed that during the tul procedure, the insertion portion of the stone retrieval device and ureteroscope (b)(4) got stuck within the ureter when the facility tried to retrieve the fragments of the stone after grasping the stone with the basket.Since the retrieval of the stone was nearly completed, the facility reportedly finished the procedure after cutting the distal portion of the stone retrieval device and left the insertion portion of the subject device and the ureteroscope (b)(4).The day after the procedure, the stone retrieval device and the ureteroscope (b)(4 )reportedly were retrieved by holding and withdrawing the part of the subject device which came out of the patient.(without additional endoscopic procedure or surgery) although the patient stayed in the hospital after the procedure, the patient is reportedly doing well.There was no patient injury report related to this event.

• Brand Name: ULTRA-CATCH NT (1.8 FRX 115 CM) STONE RETRIEVAL DEVICE
• Type of Device: STONE RETRIEVAL DEVICE
• Manufacturer (Section D): GYRUS ACMI, INC.; 6655 wedgwood road north; maple grove MN 55311 3602
• Manufacturer (Section G): GYRUS ACMI, INC.; 6655 wedgwood rd; maple grove MN 55311 3602
• Manufacturer Contact: angela caputo ; 136 turnpike rd; southborough, MA 01772 ; 5088042667
• MDR Report Key: 5274174
• MDR Text Key: 33467140
• Report Number: 2183680-2015-00005
• Device Sequence Number: 1
• Product Code: FGO
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/08/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/08/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: NT4W18115
• Device Lot Number: MK901616
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/30/2014
• 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): Hospitalization; Other