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

Model Number	G46027
Medical Device Problem Code	Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/17/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Concomitant medical products: unspecified smaller scope (under 10fr).Occupation: non-healthcare professional.Pma/510k # exempt.This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.
Event or Problem Description
It is reported during a mini percutaneous nephrolithotomy (pcnl) to remove a 3.5 cm renal stone using a ncompass nitinol tipless stone extractor, "the basket was used in a patient and the device was laid back on the table.About 15 minutes later, the physician picked up the product once more, it seemed as though the wires were more stuck together instead of a basket shape." no part of the device separated.Once this was realized, it was not used in the patient.A second basket was opened and used to complete the procedure successfully.No adverse effects to the patient have been reported as a result of this alleged product malfunction.
Additional Manufacturer Narrative
Investigation/evaluation: a visual inspection and functional testing of the returned device was conducted.A document based investigation was completed including a review of complaint history, the device history record, instructions for use, manufacturing instructions, and quality control data.One device was returned for investigation.The returned packaging confirms the reported complaint device lot number.The device was returned with the handle and the basket formation in the closed position.The support sheath is bowed in appearance.Functional testing found the handle actuates the basket formation.The basket formation does not fully expand.There is debris on the tip of the catheter.Once the debris was removed, functional testing noted the basket formation expanded fuller, but it did not expand fully.Visual examination noted the wires appear compressed at the tip of the basket formation.Debris was cleaned from the distal tip of the basket formation.It was observed that 3 wires are kinked and it appears they have been caught or snagged on.A review of the device history record shows there are no non-conformances.A review of complaint history shows no other complaints are associated with the complaint device lot number.A review of the instructions for use (ifu) found the following information related to the reported failure mode: precaution: enclose the device in the sheath before removing from the tray/holder.Precaution: do not use excessive force to manipulate this device.Damage to the device may occur.Based on the investigation evaluation, there is no indication that a design or process related failure mode contributed to this event.Current controls for manufacturing are in place to assure functionality and device integrity prior to shipping.Review of production and quality documentation did not observe any specific issues with current manufacturing or quality controls that may have contributed to this incident.The returned device was found to have a basket that would open and close, but the shape of the basket was deformed when opened, preventing the basket from forming the proper shape.Two issues were noted that caused the basket to be misshapen: a dried residue on the basket tip was affecting the shape of the basket.The dried residue was likely blood, as the provided information stated the patient had a large amount of blood clots that made it difficult to access the stone.Once the dried residue was removed, the basket still did not have the proper shape.Some of the basket wires were found to be bent / kinked.It is possible the wires became bent due to procedural factors, such as difficulty accessing the stone, or nature of the stone itself.It is likely that procedural factors encountered during the procedure caused damage to the basket wires of the device, which prevented the basket from opening fully.The investigation conclusion for this complaint is cause cannot be traced to the device; adverse event is related to patient condition.Per the quality engineering risk assessment, no further action is warranted.The appropriate internal personnel have been notified and we will continue to monitor 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 or Problem Description
No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.

• Brand Name: NCOMPASS NITINOL TIPLESS STONE EXTRACTOR
• Common Device Name: FFL DISLODGER, STONE, BASKET, URETERAL, METAL
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 8570277
• Report Number: 1820334-2019-00914
• Device Sequence Number: 1638926
• Product Code: FFL
• UDI-Device Identifier: 00827002460270
• UDI-Public: (01)00827002460270(17)220221(10)9540842
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Expiration Date: 02/21/2022
• Device Model Number: G46027
• Device Catalogue Number: NCT4-017115
• Device Lot Number: 9540842
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/30/2019
• Initial Date Received by Manufacturer: 04/17/2019
• Supplement Date Received by Manufacturer: 05/08/2019
• Initial Report FDA Received Date: 05/01/2019
• Supplement Report FDA Received Date: 05/20/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1