MAUDE Adverse Event Report: COOK INC NTRAP STONE ENTRAPMENT AND EXTRACTION DEVICE; FFL DISLODGER, STONE, BASKET, URETERAL, METAL

Model Number G32724

Device Problem Mechanical Jam (2983)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/12/2019

Event Type  malfunction  

Manufacturer Narrative

Blank fields on this form indicate the information is unknown or unavailable.Occupation: other healthcare professional.Pma/510k # exempt preamendment.(b)(4).This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.

Event Description

It is reported during an unspecified procedure at a veterinary clinic using an ntrap stone entrapment and extraction device, the provider "had a very hard time retracting and deploying it." the provider also reported " i read the directions multiple times but i obviously was not doing it right & tried to find videos to no avail.At this point i'm pretty sure i stripped it.".This device was not used.It is unknown how the procedure was completed after the difficulty.It is unknown if the patient experienced any adverse effect as a result of this alleged product malfunction.Additional information has been requested about the patient and event.At this time, no further information has bee provided.

Manufacturer Narrative

Investigation/evaluation: a visual inspection and functional testing of the returned device was conducted.A document based investigation was also performed including a review of complaint history, device history record, the instructions for use, manufacturing instructions, and quality control data.One device was returned for investigation.The device was returned with the basket formation retracted in the basket sheath 5 cm.The basket sheath is bent 25.2 cm from the proximal end.The clear sheath material is stripped starting at the handle end and extends for 2.5 cm in length and again 15 cm from the handle.The handle was returned tightened down.Functional testing determined the basket formation cannot be actuated by the handle or manually.Visual examination noted the clear sheathing is accordioned.The basket sheath is separated, and the coils are exposed.A review of the device history record found there were no non-conformances related to the reported failure mode.A review of complaint history revealed no other complaints associated with the complaint device lot.The instructions for use (ifu), provides the following information related to the reported failure mode: precautions: users should be familiar with and experienced in urological endoscopic surgery.Assess calculi or other foreign bodies prior to instrument deployment to ensure that object is not too large to be removed through the anatomy.If resistance is encountered while attempting to remove calculi or other foreign bodies, release the object.Do not exert excessive force on the device.Due to the asymmetric nature of the ntrap, do not torque or rotate the device in vivo.A review of relevant manufacturing documents was conducted.It was concluded that the device aspect in question was visually/functionally inspected by quality control and no related gaps in production or processing controls were noted.The returned device was found to have basket that was closed and it could not be opened due to extensive sheath damage.The sheath of the device was found to be buckled, stripped, and separated.The extent of the damage prevented a determination of the cause of the reported issue of the device being difficult to retract and deploy.Per the quality engineering risk assessment, no further action is warranted.Cook medical has notified the appropriate personnel and 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 additional information regarding the patient and/or event has been received since the previous medwatch report was sent.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unchanged, or unavailable.(b)(6).D:11 concomitant devices: karl storz flexi video uretero-cystoscope with 3.6fr working channel this report includes information known at this time.A follow up report will be submitted should additional relevant information become available or upon investigation completion.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

Additional information received from customer.The procedure being performed was a percutaneous cystolithotomy and urethral stone removal on an english bulldog.There was no laser machine used during the procedure.The device was tested prior to use in the uncoiled position with the handle parallel to the patient's body.There were no difficulties with the patient's anatomy keeping the basket from opening or closing.The procedure was completed by retro pulsing the stone back into the bladder and using a nitinol stone basket to retrieve it.

• Brand Name: NTRAP STONE ENTRAPMENT AND EXTRACTION DEVICE
• Type of Device: FFL DISLODGER, STONE, BASKET, URETERAL, METAL
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 8439922
• MDR Text Key: 139572463
• Report Number: 1820334-2019-00667
• Device Sequence Number: 1
• Product Code: FFL
• UDI-Device Identifier: 00827002327245
• UDI-Public: (01)00827002327245(17)211226(10)9404731
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 05/20/2019

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 Expiration Date: 12/26/2021
• Device Model Number: G32724
• Device Catalogue Number: NTP-028145
• Device Lot Number: 9404731
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/09/2019
• Initial Date Manufacturer Received: 03/13/2019
• Initial Date FDA Received: 03/21/2019
• Supplement Dates Manufacturer Received: 03/25/2019; 05/11/2019
• Supplement Dates FDA Received: 04/19/2019; 05/20/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Weight: 35