MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION UROMAX ULTRA; DILATOR, CATHETER, URETERAL

Model Number M0062251170

Device Problems Burst Container or Vessel (1074); Material Deformation (2976)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/31/2022

Event Type  malfunction  

Event Description

It was reported to boston scientific corporation that a uromax ultra dilatation balloon catheter was used in the kidney during a lithotripsy procedure performed on (b)(6) 2022.During the procedure, the balloon was inflated once; however, the balloon ruptured when it was inflated for the second time at 20 atm.The procedure was completed with another uromax ultra dilation balloon catheter.Note: a photo submitted by the customer shows the balloon was burst and the catheter was kinked at the middle section.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

Block h6: medical device code a0402 captures the reportable event of balloon ruptured.Medical device code a0406 captures the reportable event of catheter kinked.Block h10: investigation result the returned uromax ultra balloon was analyzed, and a visual evaluation noted that the balloon was not folded with inflation media present inside of it which indicates that the balloon was subjected to positive pressure.Functional evaluation was performed by attaching the device into an inflation unit and the balloon was able to inflate to its rated burst pressure for 30 seconds without problem.The balloon was inflated and deflated three times repeatedly with no leaks or drop of pressure noted.No problems were identified on the balloon material.A visual and tactile examination revealed that there were no problems found on the markerband and the tip of the device.A visual and tactile examination were also performed to the catheter shaft, and it was found that the shaft was severely kinked at the proximal markerband.No other problems with the device were noted.A photo of the device submitted by the customer was reviewed which confirmed the kinked on the shaft of the device.The reported event of catheter kinked was confirmed; however, the event of balloon bursting was not confirmed.It is possible that the kinked found on the shaft occurred when the user was attempting to position the device.The returned device review showed no evidence of either the alleged(s) or any defect which could have contributed to the event (visual, physical and performance testing).Therefore, the most probable root cause for this complaint is no problem detected.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.A labeling review was performed and from the information available, this device was used per the instructions for use (ifu)/product label.

Event Description

It was reported to boston scientific corporation that a uromax ultra dilatation balloon catheter was used in the kidney during a lithotripsy procedure performed on (b)(6) 2022.During the procedure, the balloon was inflated once; however, the balloon ruptured when it was inflated for the second time at 20 atm.The procedure was completed with another uromax ultra dilation balloon catheter.Note: a photo submitted by the customer shows the balloon was burst and the catheter was kinked at the middle section.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.

• Brand Name: UROMAX ULTRA
• Type of Device: DILATOR, CATHETER, URETERAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC IRELAND LIMITED; ballybrit business park; galway ; EI
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 15527452
• MDR Text Key: 301013238
• Report Number: 3005099803-2022-05516
• Device Sequence Number: 1
• Product Code: EZN
• UDI-Device Identifier: 08714729341253
• UDI-Public: 08714729341253
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K980795
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/03/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/03/2022
• Device Model Number: M0062251170
• Device Catalogue Number: 225-117
• Device Lot Number: 0024541479
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/06/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/04/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 50 YR
• Patient Sex: Male
• Patient Weight: 65 KG