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

Catalog Number NTRSE-100038

Device Problem Material Separation (1562)

Patient Problem Foreign Body In Patient (2687)

Event Date 11/17/2021

Event Type  Injury  

Event Description

As reported, approximately one year after a lithotripsy with stone removal in which a perc ncircle nitinol tipless stone extractor and another manufacturer's nitinol stone retrieval basket were used, a nitinol basket was discovered in the patient's renal pelvis with a large stone detached.This was identified during a foreign body retrieval procedure.It is unknown which of the two devices separated and remained in the patient.Additional event information has been requested.

Manufacturer Narrative

Boston scientific zero tip nitinol stone retrieval basket (m0063901050).Pma/510(k) #- exempt.This report includes information known at this time.A follow-up report will be submitted should additional relevant information become available.

Event Description

Additional information received 28feb2022.The reporting facility is unable to determine the lot number of the device.According to the medical record, the patient was readmitted for a cystoscopy, left retrograde phylogram, left ureteroscopy, and attempted extraction of the foreign object.During this procedure, the attempt to extract the object was unsuccessful.The patient was then readmitted for left ureteroscopy, where the foreign object was removed.The size of the stone is unknown.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown or unavailable.B5: additional information received 28feb2022.This report includes information known at this time.A follow-up report will be submitted should additional relevant information become available.This report is required by the fda under 21 cfr part 803 and is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement contained herein is intended to be an admission that any cook device is defective or malfunctioned, that a death or serious injury occurred, nor that any cook device caused, contributed to, or is likely to cause or contribute to a death or serious injury if a malfunction occurred.

Manufacturer Narrative

Blank fields on this form indicate the information is unchanged, unknown or unavailable.Event summary as reported, approximately one year after a lithotripsy with stone removal in which a perc ncircle nitinol tipless stone extractor and another manufacturer's nitinol stone retrieval basket were used, a nitinol basket was discovered in the patient's renal pelvis with a large stone detached.This was identified during a foreign body retrieval procedure.It is unknown which of the two devices separated and remained in the patient.The reporting facility is unable to determine the lot number of the device.According to the medical record, the patient was readmitted for a cystoscopy, left retrograde phylogram, left ureteroscopy, and attempted extraction of the foreign object.During this procedure, the attempt to extract the object was unsuccessful.The patient was then readmitted for left ureteroscopy, where the foreign object was removed.The size of the stone is unknown.Investigation - evaluation a document-based investigation was performed including a review of instructions for use (ifu) and quality control data.The complaint device was not returned; therefore, no physical examinations could be performed.The fragment of the device was found to have been left inside the patient was not returned.No photographs were provided.A review of the device history record could not be completed due to lack of lot information from the user facility.A review of the complaint history could not be completed due to lack of information from the user facility.The instructions for use (ifu) provides the following information to the user related to the reported failure mode: important: excessive force could damage device.A clinical assessment was completed and noted the following: based on the information provided for this clinical assessment, it could not be confirmed if the separated device piece belonged to the cook stone retrieval basket or the boston scientific stone retrieval basket as no device was returned or pictures were provided.However, if the device was a cook perc ncircle nitinol tipless stone extractor, the most probable cause of this event would likely be related to user/procedural issues and/or concomitant device use (laser).No complaint device was returned, nor were any pictures provided.It could not be determined if the device was manufactured by cook medical or boston scientific, as both devices had been used in the previous stone removal procedure.It was not possible to confirm that a cook medical device had separated and remained in the patient.Per the quality engineering risk assessment, no further action is warranted.Cook medical will continue to monitor this device via the complaints database for similar complaints.This report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.

Event Description

No new patient or event information since the last report was submitted.

• Brand Name: PERC NCIRCLE NITINOL TIPLESS STONE EXTRACTOR
• Type of Device: FFL DISLODGER, STONE, BASKET, URETERAL, METAL
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer (Section G): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: jason crouch ; 750 daniels way; bloomington, IN 47404 ; 8128294891
• MDR Report Key: 13533778
• MDR Text Key: 285612386
• Report Number: 1820334-2022-00225
• Device Sequence Number: 1
• Product Code: FFL
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup,Followup
• Report Date: 04/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: NTRSE-100038
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/19/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Other; Required Intervention
• Patient Age: 53 YR