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

Model Number	M0062251310
Medical Device Problem Codes	Burst Container or Vessel (1074); Inflation Problem (1310)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/24/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that the a uromax ultra dilation balloon catheter was used in the urethra during a ureter stenosis procedure performed on (b)(6) 2021.During the procedure, it was noticed that the balloon was damaged when inflated to 16 atm.The procedure was completed with another uromax ultra dilation balloon catheter.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.
Additional Manufacturer Narrative
(b)(4).The complainant indicated that the device was disposed and will not be returned for evaluation; therefore, a failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.
Event or Problem Description
It was reported to boston scientific corporation that the a uromax ultra dilation balloon catheter was used in the urethra during a ureter stenosis procedure performed on (b)(6) 2021.During the procedure, it was noticed that the balloon was damaged when inflated to 16 atm.The procedure was completed with another uromax ultra dilation balloon catheter.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.Additional information received on december 24, 2021.It was clarified that the only damaged noticed was the balloon would just not inflate.
Additional Manufacturer Narrative
Block h2: additional information: block b5 (describe event or problem), block e1 (initial reporter address 1, initial reporter address 2, initial reporter city and initial reporter zip/post code), and block h10.Conclusion code d17 is being used in lieu of an adequate conclusion code for device not returned block h10: the complainant indicated that the device was disposed and will not be returned for evaluation; therefore, a failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.Block h11: correction: h6 (device codes).

• Brand Name: UROMAX ULTRA KIT
• Common Device Name: 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: 13087216
• Report Number: 3005099803-2021-07959
• Device Sequence Number: 12118061
• Product Code: KOE
• UDI-Device Identifier: 08714729341383
• UDI-Public: 08714729341383
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K980795
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/21/2022

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: 10/23/2023
• Device Model Number: M0062251310
• Device Catalogue Number: 225-131
• Device Lot Number: 0026622749
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 11/29/2021
• Supplement Date Received by Manufacturer: 12/24/2021
• Initial Report FDA Received Date: 12/27/2021
• Supplement Report FDA Received Date: 01/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/23/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 45 YR
• Patient Sex: Female
• Patient Weight: 52 KG