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

Model Number	M0062251160
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/01/2021
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 was used during an ureteroscopy procedure performed on (b)(6) 2021.During the procedure, when the physician opened the package the balloon was noted to have a significant bend.The procedure was completed with another uromax ultra dilatation balloon catheter.There were no patient complications reported as a result of this event.
Event or Problem Description
It was reported to boston scientific corporation that a catheter was used during an ureteroscopy procedure performed on(b)(6), 2021.During the procedure, when the physician opened the package the balloon was noted to have a significant bend.The procedure was completed with another uromax ultra dilatation balloon catheter.There were no patient complications reported as a result of this event.***additional information received on (b)(6)2021*** it was reported that the uromax ultra dilatation balloon catheter was used in the ureter.
Additional Manufacturer Narrative
Additional information: block b5 (describe event or problem), d7a (sud reprocessed and reused?) and h8 (usage of device) block h6: device code a0406 captures the reportable issue of balloon kinked.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.

• 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: 12224835
• Report Number: 3005099803-2021-03785
• Device Sequence Number: 4370882
• Product Code: KOE
• UDI-Device Identifier: 08714729341246
• UDI-Public: 08714729341246
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K130804
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/11/2021

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: 02/16/2024
• Device Model Number: M0062251160
• Device Catalogue Number: 225-116
• Device Lot Number: 0026814920
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/01/2021
• Supplement Date Received by Manufacturer: 07/22/2021
• Initial Report FDA Received Date: 07/26/2021
• Supplement Report FDA Received Date: 08/11/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1