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

Catalog Number 010015

Device Problem Difficult to Advance (2920)

Patient Problem No Code Available (3191)

Event Date 12/10/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).A follow up report will be submitted should additional relevant information become available.

Event Description

It is reported during a ureteroscopy to remove a proximal ureteral stone using an ureteral balloon dilator, the physician found that the ureteral balloon dilator only enables the enclosed wire to fit so that a 0.035 or 0.038 wire cannot be used over which to dilate.The physician also stated he felt that the wire included in the kit was more flimsy, did not stay in place as well, and due to both of these factors it kinked more easily.After kinking it then became much harder to move the balloon catheter over the wire.Ultimately, the procedure could not be completed due to this difficulty.The patient was stented and will have to return to the or in a few weeks for a subsequent procedure.No additional consequences to the patient have been reported as a result of this occurrence.

Event Description

No new patient or event information since last report.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unchanged, or unavailable.Investigation ¿ evaluation: h6: ec results code: (4247) appropriate code not available: customer dissatisfaction.Event description cook was informed on 12/11/2019 of an incident involving a ureteral balloon dilator rpn 010015 from an unknown lot.The wire guide provided with the device reportedly kinked during a ureteroscopy procedure to remove proximal ureteral stones on (b)(6) 2019.A visual inspection of the complaint device could not be performed as the device was not returned.A document based investigation was performed including a review of documentation, instructions for use, and specifications.Cook could not complete a review of the device history record (dhr) due to lack of lot information from the user facility.Because adequate inspection activities have been established, it was concluded that there is no evidence that nonconforming product exists in house or in field.Cook could not complete a search of other complaints associated with the complaint device lot number due to lack of lot information from the user facility.Cook reviewed product labeling.The product ifu for this device provides the following information to the user: note: set components may vary.If not 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 that the 5.0 french size device used in the procedure accepts a.028" wire guide.A.028" wire guide was supplied with the complaint device.No product were returned.No were photos provided.The lot number was unknown, so other product from the same lot could not be obtained for investigation.The risk specification for this product includes the kinking or wire guide failure mode and identifies the risk controls that are in place to mitigate the risk of this type of failure.There is no indication from the document review that there is nonconforming product in the field.Based on the provided information, the user was experienced with the 7.0 french size balloon catheter that is supplied with a.038" wire guide, but was using a 5.0 french size balloon catheter that is supplied with a.028" wire guide.The smaller size of the balloon catheter and wire guide resulted in the issues such as kinking experienced by the user when compared to the larger size device.The conclusion of the investigation is that the cause of the complaint was an unintended error where the user was expecting performance characteristics of a 7.0 french size device when using a 5.0 french size device.The risk documentation procedures were reviewed, and it was determined that no actions are required.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: URETERAL BALLOON DILATOR
• Type of Device: EZN DILATOR, CATHETER, URETERAL
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 9535958
• MDR Text Key: 185095427
• Report Number: 1820334-2019-03176
• 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: 04/06/2020

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
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Weight: 77