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

Model Number	M0062251080
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/28/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Although the suspect device has been received, the evaluation has not been completed.Therefore, the cause of the reported malfunction has not been determined.Upon completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental mdr will be filed.
Event or Problem Description
It was reported to boston scientific corporation that a uromax ultra dilation balloon catheter device was used in the right ureter during a ureteroscopy (urs) procedure performed on (b)(6) 2021.During the procedure, when the contrast was injected to the balloon it was noticed that there was no pressure.The c-arm was checked and noted to have a leak from a small hole 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 condition at the conclusion of the procedure was reported to be good.
Additional Manufacturer Narrative
Block h6: medical device code a041001 captures the reportable issue of balloon pinhole.Block h10: investigation result: a visual examination of the returned device found that the balloon was not folded which indicated that the device was subjected to positive pressure.It was also observed that liquid was leaking from a balloon pinhole.A visual and tactile examination found no damage or kinks to the shaft of the device.A microscopic examination found no issue with the tip and markerbands that could have potentially contributed to the complaint incident.Based on the available information, it is possible that the device indicates the requirement for dilatation the device may have encountered difficult lesion complexity such as stenosis, calcification or tortuosity which would have contributed to the complaint incident.Therefore, the most probable root cause is adverse event related to procedure.A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly and performance specifications.A labeling review was performed and from the information available, this device was used per the instructions for use (ifu)/product label.
Event or Problem Description
It was reported to boston scientific corporation that a uromax ultra dilation balloon catheter device was used in the right ureter during a ureteroscopy (urs) procedure performed on (b)(6) 2021.During the procedure, when the contrast was injected to the balloon it was noticed that there was no pressure.The c-arm was checked and noted to have a leak from a small hole 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 condition at the conclusion of the procedure was reported to be good.

• 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: 11372349
• Report Number: 3005099803-2021-00717
• Device Sequence Number: 19776493
• Product Code: KOE
• UDI-Device Identifier: 08714729341185
• UDI-Public: 08714729341185
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/24/2021

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: 07/03/2022
• Device Model Number: M0062251080
• Device Catalogue Number: 225-108
• Device Lot Number: 0024057384
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/18/2021
• Initial Date Received by Manufacturer: 01/28/2021
• Supplement Date Received by Manufacturer: 03/02/2021
• Initial Report FDA Received Date: 02/24/2021
• Supplement Report FDA Received Date: 03/24/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 64 YR