Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC - GALWAY UROMAX ULTRA¿; DILATOR, CATHETER, URETERAL
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

BOSTON SCIENTIFIC - GALWAY UROMAX ULTRA¿; DILATOR, CATHETER, URETERAL Back to Search Results
Model Number M0062251160
Device Problem Material Deformation (2976)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 04/13/2018
Event Type  malfunction  
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.(b)(4).
 
Event Description
It was reported to boston scientific corporation that a uromax ultra dilatation balloon device was used during a procedure performed on (b)(6) 2018.According to the complainant, during preparation, it was noted that the catheter would bent or kink.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 fine.
 
Manufacturer Narrative
Investigation results: visual examination of the complaint device confirmed the reported event.The shaft of the device was kinked distal to the strain relief.No other issues were noted with the device.Based on the analysis performed and the information provided, the most probable root cause for the complaint event is handling damage.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, there was no evidence that the device was used in a manner inconsistent with the labeled indications.
 
Event Description
It was reported to boston scientific corporation that a uromax ultra dilatation balloon device was used during a procedure performed on (b)(6) 2018.According to the complainant, during preparation, it was noted that the catheter would bent or kink.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 fine.Additional information received on may 04, 2018.It was reported to boston scientific corporation that a uromax ultra dilatation balloon device was used in the right ureter during a right ureteral dilation procedure performed on (b)(6) 2018.According to the complainant, during preparation, it was noted that the catheter was already bent inside the packaging.The procedure was completed with another uromax ultra dilatation balloon device.
 
Event Description
It was reported to boston scientific corporation that a uromax ultra dilatation balloon device was used during a procedure performed on (b)(6) 2018.According to the complainant, during preparation, it was noted that the catheter would bent or kink.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 fine.Additional information received on may 04, 2018.It was reported to boston scientific corporation that a uromax ultra dilatation balloon device was used in the right ureter during a right ureteral dilation procedure performed on (b)(6) 2018.According to the complainant, during preparation, it was noted that the catheter was already bent inside the packaging.The procedure was completed with another uromax ultra dilatation balloon device.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
UROMAX ULTRA¿
Type of Device
DILATOR, CATHETER, URETERAL
Manufacturer (Section D)
BOSTON SCIENTIFIC - GALWAY
MDR Report Key7483911
MDR Text Key107362247
Report Number3005099803-2018-01434
Device Sequence Number1
Product Code EZN
Combination Product (y/n)N
PMA/PMN Number
K980795
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup,Followup
Report Date 04/20/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/03/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date02/04/2021
Device Model NumberM0062251160
Device Catalogue Number225-116
Device Lot Number0021700428
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/26/2018
Date Manufacturer Received05/28/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age83 YR
-
-