MAUDE Adverse Event Report: COOK INC NCIRCLE DELTA WIRE TIPLESS STONE EXTRACTOR; FFL DISLODGER, STONE, BASKET, URETERAL, METAL

Model Number N/A

Device Problems Difficult to Remove (1528); Device Operates Differently Than Expected (2913)

Patient Problems Foreign Body In Patient (2687); Device Embedded In Tissue or Plaque (3165)

Event Date 05/03/2017

Event Type  Injury  

Manufacturer Narrative

Patient code: fragments in patient, foreign body in patient.Device code: device operates differently than expected and difficult to remove are not labeled.The event is currently under investigation.A follow-up report will be submitted upon receipt of additional information or completion of the investigation.

Event Description

It was reported that the physician was performing an intended ureteroscopy with laser lithotripsy on left kidney of the patient.The physician treated two stones out of three with holmium laser and removed the fragments.The physician¿s intent was to reposition the 3rd stone (1.1cm in size) from the lower pole of the kidney prior to treatment.The physician used the ncircle delta wire tipless stone extractor basket to extract the third stone from the calyx.He was able to deploy the basket around the stone, but was unable to extract it from the calyx due to its larger size, and was also unable to remove the stone from the basket.The physician had to cut the handle from the ncircle delta wire tipless stone extractor, remove the scope, and re-insert it next to the wire shaft of the basket in the ureter.He then attempted to use the laser to break up the stone or cut the basket to remove it but he was unable to deflect the scope enough to get clear access to the stone.The physician decided to stent the patient and to perform an extracorporeal shock wave lithotripsy (eswl) procedure so he can remove the basket once the stone is fragmented.The nitinol core of the basket (outer sheath removed) as well as the tip of the basket remained inside the patient.The proximal basket tip secured around the stone in the lower pole of the kidney, and the distal end of the wire was exiting the vagina, where it was covered and secured until the patient could be returned for an additional procedure.The patient was brought back in for an eswl on the next day.The eswl was unsuccessful in breaking up the stone, and at this time the device remained inside the patient.The physician is consulting with other providers.The physician's expectation is that he will have to schedule a percutaneous access to remove the device.The patient required an additional procedure due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.

Manufacturer Narrative

Corrected information: the device was not available for evaluation.Investigation - evaluation: the ncircle delta wire tipless stone extractor was not returned/received for an evaluation.The customer report of the unable to retrieve the basket or remove the stone from the basket could only be confirmed based on the customer¿s testimony.Based on the information available a definitive root cause could not be established.A review of production and quality documentation did not identify any specific issues with current manufacturing or quality controls that may have contributed to this incident.A review of the device history record showed there were no non-conformances identified during the manufacturing process that would have caused or contributed to the identified product issue.A review of complaint history revealed this complaint to be the only complaint received that is associated with this product/lot number combination.Per the quality engineering risk assessment; no further action is required.Cook medical has notified the appropriate personnel and the will continue to monitor this device via the complaints database for similar complaints.

• Brand Name: NCIRCLE DELTA WIRE TIPLESS STONE EXTRACTOR
• Type of Device: FFL DISLODGER, STONE, BASKET, URETERAL, METAL
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: larry pool ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 6601333
• MDR Text Key: 76302062
• Report Number: 1820334-2017-01080
• Device Sequence Number: 1
• Product Code: FFL
• UDI-Device Identifier: 00827002191105
• UDI-Public: (01)00827002191105(17)200317(10)7759259
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 08/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/31/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: NTSED-024115-UDH
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/27/2017
• Date Device Manufactured: 03/17/2017
• 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
• Patient Age: 67 YR