MAUDE Adverse Event Report: GYRUS ACMI, INC ULTRA-CATCH NT (2.2 FR X 115 CM) STONE RETRIEVAL DEVICE

Model Number NT4W22115

Device Problem Sticking (1597)

Patient Problem No Consequences Or Impact To Patient (2199)

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 device got stuck around a stone in the ureter.The ureter was large enough to extract the stone, but then the ostium appeared to be too small.Ultra catch sat around the stone and did not come loose anymore.Loosen at the end of the handle and pulled the sleeve off, but the wires of the basket did not loosen themselves.And stayed around the stone.Swapped from flex scoop to semi rigid and making with the lithoclast the stone smaller.Then the last part could be removed ultra catch.

Manufacturer Narrative

The lot# could not be confirmed since no original packaging was returned with the device.The device was returned in a small bag (6"x 11")coiled inside about 4 times.Visual inspection revealed the wire and outer sheath had been cut part way through the heat shrink and were separate from each other.The thumbslide was in the deployed position and moves easily until the bent core wire portion left in the handle catches on the heat shrink.The outer sheath was cut 13/16" from the end of the heat shrink and the wire 1" from the end of the heat shrink.The basket appears to be in good condition.The wire twists at the disc are uniform.Further inspection of the sheath found a kink at 5 1/2 inches from one end.It does not appear that there is any material missing from the outer sheath or core wire.It doesn't appear that there was any device failure but rather the issue was a large stone in a part of the anatomy too small to remove it.The staff had to cut the device apart and make the stone smaller in order to remove the basket from the patient.The customer's complaint could not be reproduced due to the condition of the device.It doesn't appear that there was any device failure but rather the issue was a large stone in a part of the anatomy too small to remove it.The staff had to cut the device apart and make the stone smaller in order to remove the basket from the patient.

• Brand Name: ULTRA-CATCH NT (2.2 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
• MDR Report Key: 6856423
• MDR Text Key: 86009391
• Report Number: 3011050570-2017-00007
• Device Sequence Number: 1
• Product Code: FGO
• Combination Product (y/n): N
• PMA/PMN Number: PEXEMPT-FGO
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 01/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/11/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: NT4W22115
• Device Lot Number: MK915810
• Other Device ID Number: UDI
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/25/2017
• Date Manufacturer Received: 01/15/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention