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

Model Number	M0062251000
Medical Device Problem Codes	Burst Container or Vessel (1074); Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/27/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).According to the complainant, the suspect device has been disposed and is not available for return.If any further relevant information is received, a supplemental mdr will be filed.
Event or Problem Description
It was reported to boston scientific corporation that a uromax ultra dilatation balloon catheter device was used in the ureter during a ureteroscopy procedure performed on (b)(6) 2019.According to the complainant, during the procedure, the balloon was attempted to be inflated; however it would not inflate.Reportedly, the balloon was inspected and a small hole was noted.The procedure was completed with another uromax ultra dilatation balloon catheter device.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Correction: block b5 and h6 additional information: block b5 block h6: problem code 1504 captures the reportable event of balloon pinhole.Block h10: according to the complainant, the suspect device has been disposed and is not available for return.If any further relevant information is received, a supplemental mdr will be filed.
Event or Problem Description
It was reported to boston scientific corporation that a uromax ultra dilatation balloon catheter device was used in the ureter during a ureteroscopy procedure performed on (b)(6), 2019.According to the complainant, during the procedure, the balloon was attempted to be inflated; however it would not inflate.Reportedly, the balloon was inspected and a small hole was noted.The procedure was completed with another uromax ultra dilatation balloon catheter device.There were no patient complications reported as a result of this event.**additional information received on (b)(6)2020** according to the complainant, during the procedure, the balloon burst while inflating to 17 atm.

• Brand Name: UROMAX ULTRA
• Common Device Name: DILATOR, CATHETER, URETERAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 9756169
• Report Number: 3005099803-2020-00551
• Device Sequence Number: 2184946
• Product Code: EZN
• UDI-Device Identifier: 08714729341109
• UDI-Public: 08714729341109
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: K130804
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/24/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 01/03/2020
• Device Model Number: M0062251000
• Device Catalogue Number: 225-100
• Device Lot Number: 0020117576
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/03/2020
• Supplement Date Received by Manufacturer: 03/04/2020
• Initial Report FDA Received Date: 02/26/2020
• Supplement Report FDA Received Date: 03/24/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1