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

Model Number NT4W18115

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/12/2016

Event Type  malfunction  

Manufacturer Narrative

The device was returned to olympus and will be sent to the oem for evaluation.The cause of the reported event cannot be determined; however, the mostly likely cause of the reported event can be attributed to a higher than normal force applied on the joint by the operator when extracting a large stone.The instruction manual warns users: certain objects may be too large to remove endoscopically with this retrieval system.To avoid complications fluoroscopic x-ray or some means of identification of an objects size should be used prior to attempting to remove.Do not use this device if the object is too large to be removed and/or cannot be securely held in the stone dislodger.Inspect the device for any visible damage such as kinks or broken stone dislodger wires.Test the device by opening, closing and rotating it several times before being introduced into the patient.

Event Description

Olympus was informed that during a laser lithotripsy procedure, the basket broke off and fell into the patient.The physician used another device and retrieved the basket.It was reported that the physician¿s retrieval delayed the procedure 45 minutes.There was no bleeding reported.The intended procedure was completed with a different device.There was no patient injury.

Manufacturer Narrative

This supplemental report is being submitted to provide the device evaluation results.The device was returned to the oem for investigation.A visual inspection of the device was performed and found that the basket was not retuned; however, the remainder of the device was coiled up with the thumb slide in a partial deployed position.The hypo tube was still attached to the core wire and about 0.234¿ from the end of the sheath.During visual inspection it was noted that there were 2 kinks in the sheath; one at 2.75¿ and the other 0.141¿ from the distal end of the sheath.The welds on the hypo tube were inspected under a microscope and no anomalies were found as the welds measured within manufacture¿s specification.A review of the device history reveals that there were no anomalies noted during the manufacturing of this device.Due to the basket not being returned and based on the investigation findings, the most likely cause of the reported event is either the welds on the hypo tube did not penetrate deep enough to secure the basket wire bundle or the basket wire bundle did not get located properly in the hypo tube prior to the welding process.

• Brand Name: ULTRA-CATCH NT (1.8 FR X 115 CM) STONE RETRIEVAL DEVICE
• Type of Device: STONE RETRIEVAL BASKET
• Manufacturer (Section D): OSTA; 136 turnpike road; southborough MA 01772
• Manufacturer Contact: connie tubera ; 2400 ringwood avenue; san jose, CA 95131 ; 408935-512
• MDR Report Key: 5995070
• MDR Text Key: 56813004
• Report Number: 2951238-2016-00777
• Device Sequence Number: 1
• Product Code: FGO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PEXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/14/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: NT4W18115
• Device Catalogue Number: NT4W18115
• Device Lot Number: MK610984
• Other Device ID Number: UDI
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/28/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/13/2016
• Initial Date FDA Received: 10/03/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/15/2016
• Was Device Evaluated by Manufacturer?: No
• 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