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 was reported that a (b)(6) female underwent a percutaneous nephrolithotomy.Cook's flexi-tip dual-lumen ureteral access set, (gpn:(b)(4)) was utilized during this case.A nephroscope was used concomitantly with cook's device.During the case it was observed that pieces of the dual lumen sheared off in the patient's kidneys.The fragments were flushed out of the kidneys with saline and will be returned to the manufacturer for evaluation.The procedure was completed as usual.No additional procedures were needed and the patient did not experience any adverse effects, nor were any adverse events reported as a result of this issue.The patient was discharged from the hospital (b)(6) 2019.

Event Description

There is no new event information to report.

Manufacturer Narrative

Investigation/evaluation: a visual inspection of the returned device was conducted.A document based investigation was also performed including a review of complaint history, the device history record, instructions for use, quality control data, and specifications.The complainant returned a piece of catheter material inside a specimen cup for investigation.Visual examination revealed the shaving had ink marks.Approximate length of the shaving is 3.5cm long.Color of shaving is the same as a aq-022610 flexi-tip dual-lumen ureteral catheter.The catheter was not returned.A review of the device history record revealed there are no non-conformances on the complaint device lot.A review of complaint history shows one additional complaint associated with reported complaint lot number.The second complaint is for the same issue from the same user facility.A review of the instructions for use (ifu) found the following information contained in the ifu that would help to alleviate the failure mode in this complaint.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.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.There is no indication that a design process or related failure mode contributed to this event.Current controls for manufacturing are in place to assure functionality and device integrity prior to shipping.The cause for this event could not be determined 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 suggesting nonconforming products exist in the field.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.

• 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: 8458329
• MDR Text Key: 140167564
• Report Number: 1820334-2019-00664
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/27/2019
• Initial Date Manufacturer Received: 03/08/2019
• Initial Date FDA Received: 03/27/2019
• Supplement Dates Manufacturer Received: 05/08/2019
• Supplement Dates FDA Received: 05/17/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 70 YR
• Patient Weight: 54