MAUDE Adverse Event Report: COOK INC FLEXI-TIP DUAL-LUMEN URETERAL ACCESS SET; EYB CATHETER, URETERAL, GASTRO-UROLOGY

Model Number G17323

Device Problem Material Separation (1562)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/12/2019

Event Type  malfunction  

Manufacturer Narrative

(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 has been reported that a (b)(6) year old female underwent a percutaneous nephrolithotomy.This case utilized cook's flexi-tip dual-lumen ureteral access set (gpn: g17323).A nephroscope was used concomitantly with the cook set.During this procedure it was discovered that pieces of the dual lumen sheared off in the patient's kidneys.The pieces were flushed out of the kidneys with saline and no additional procedures were required.The procedure was completed.The patient did not experience any adverse effects due to this occurrence and was discharged with no issues.The device is not available for return to the manufacturer for evaluation.

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.Investigation ¿ evaluation.The complaint device was not returned for an evaluation.Therefore, a device failure analysis could not be performed.A document based investigation was conducted including a review of complaint history, the device history record, instructions for use, quality control data, and specifications.A review of the device history record found there were no non-conformances.A review of complaint history records revealed one additional complaint received from the same user facility for the same issue for the same complaint device lot.A review of the instructions for use (ifu) identified the following information related to the reported failure mode.Note: prior to use, immerse aq catheter in sterile water or isotonic saline to allow the hydrophilic surface to absorb water and become lubricious.This will ease placement under standard conditions.1.Pass the appropriate size wire guide into the renal pelvis.There is no information provided in the ifu instructing the user to completely prevent the failure mode described in this complaint.The origin of the catheter shaving could not be determined, but is not meant to occur as a result of the intended use of the device.While it cannot be confirmed, it is possible the wire guide or nephroscope may have contributed to the shaving of the catheter.No device was returned for examination.In the related complaint, a shaving of the catheter was returned that had been sheared off during the procedure.The cause cannot be determined in this instance but is most closely associated with user technique and/or use in conjunction with a device that caused part of the lumen to shear off.There is no evidence to suggest the device was not manufactured to specifications.A definitive conclusion could not be established.A quality engineer risk assessment was conducted to assess the risk of this failure mode and concluded no additional risk reduction activities are required at this time.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.

• Brand Name: FLEXI-TIP DUAL-LUMEN URETERAL ACCESS SET
• Type of Device: EYB CATHETER, URETERAL, GASTRO-UROLOGY
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 8458558
• MDR Text Key: 140152381
• Report Number: 1820334-2019-00663
• Device Sequence Number: 1
• Product Code: EYB
• UDI-Device Identifier: 00827002173231
• UDI-Public: (01)00827002173231(17)220110(10)9435863
• Combination Product (y/n): N
• PMA/PMN Number: K962004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 05/17/2019

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: 01/10/2022
• Device Model Number: G17323
• Device Catalogue Number: AQ-022610
• Device Lot Number: 9435863
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/08/2019
• Initial Date FDA Received: 03/27/2019
• Supplement Dates Manufacturer Received: 05/06/2019
• Supplement Dates FDA Received: 05/17/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 36 YR
• Patient Weight: 59