MAUDE Adverse Event Report: COOK INC URETERAL BALLOON DILATOR; EZN DILATOR, CATHETER, URETERAL

Catalog Number 010015

Device Problem Difficult to Advance (2920)

Patient Problems Internal Organ Perforation (1987); No Code Available (3191)

Event Date 12/19/2019

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 during an unspecified procedure using a ureteral balloon dilator to dilate a proximal ureteral stricture, the physician could not be certain that the second wire (the wire from the kit) was through the true lumen because placing that wire with a dual wire introducer created some contrast extravasation.Due to this, the physician had to abort the procedure and place a stent.No additional consequences to the patient have been reported.Additional details regarding the patient and procedure have been requested.At this time, no additional information has been provided.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unchanged, or unavailable.Investigation ¿ evaluation a user facility informed cook on (b)(6) 2019 of an incident involving a ureteral balloon dilator.The ureteral lumen of the device reportedly was too narrow during an unspecified procedure on (b)(6) 2019.Further communication with the user facility clarified that the user was dissatisfied with the lumen diameter of the device.The user stated that ¿the main issue in this case was that the ureteral lumen was narrow enough that two wires could not fit across the stricture easily.I was not going to replace my sensor wire (used as a safety wire) with the wire in the dilation kit.With the older balloon dilator, i could have advanced the catheter along the sensor wire as i knew it was the true lumen.But, i could not be certain that the second wire (the wire from the kit) was through the true lumen because placing that wire with a dual wire introducer created some contrast extravasation.Therefore, i had to abort this case as well and place a stent.¿ a document based investigation was performed including a review of documentation, drawings, the instructions for use, and specifications.The complaint device was not returned; therefore, no physical examinations could be performed; however, a document based investigation evaluation was performed.There is no evidence to suggest the product was made out of specifications.The lot number of the device is not known; accordingly, a review of the device history record could not be conducted.The instructions for use (ifu), provides the following information to the user related to the reported failure mode: note: set components may vary.If no wire guide is included in this set, the following is recommended: 5.0 french balloons accept a.028" wire guide.7.0 french balloons accept a.038" wire guide.The information listed in the ifu states the proper sized wire guide to be used depending on the french size of the device being used.No product was returned.No photos were provided.The lot number was unknown, so other product from the same lot could not be obtained for investigation.Based on the provided information, the user was experienced with the 7.0 french size balloon catheter that has a 0.040 inch lumen, but was using a 5.0 fr sized device that has a 0.030 inch lumen.The smaller lumen did not allow use of the same techniques that the user was experienced with.The user refers to an older version of the device.A second complaint (pr (b)(4) was also reported by the same customer that is also related to size of the rpn 010015 device.It appears that the user was experienced using the 7.0 fr size balloon dilator, but had been supplied with 5.0 fr sized dilators and experienced issues due to the smaller diameter of the balloon dilator and wire guide.The conclusion of the investigation is that the cause of the complaint was a user preference issue in that the user preferred the larger size (7.0 fr) device.The user selected the wrong type of device for the case, a rpn 010015 balloon dilator as opposed to a rpn 010014 device.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 new patient or event information has been received since the last report was submitted.

• Brand Name: URETERAL BALLOON DILATOR
• Type of Device: EZN DILATOR, CATHETER, URETERAL
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 9535955
• MDR Text Key: 178334118
• Report Number: 1820334-2019-03175
• Device Sequence Number: 1
• Product Code: EZN
• Combination Product (y/n): N
• PMA/PMN Number: K813278
• 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: 03/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/31/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 010015
• Device Lot Number: UNKNOWN
• Date Manufacturer Received: 03/06/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention