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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ULTRATOME XL; SNARE, FLEXIBLE
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BOSTON SCIENTIFIC CORPORATION ULTRATOME XL; SNARE, FLEXIBLE Back to Search Results
Model Number M00535900
Device Problem Positioning Problem (3009)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 04/17/2019
Event Type  malfunction  
Manufacturer Narrative
The complainant was unable to report the lot number; therefore the manufacture date and expiration date are unknown.(b)(4).The device has not been received for analysis.Upon receipt and 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 Description
It was reported to boston scientific corporation that an ultratome xl was in the duodenum during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2019.According to the complainant, during the procedure, the orientation of catheter tip and cutting wire were incorrect.The procedure was completed with a second ultratome xl.There were no patient complications reported as a result of this event.
 
Event Description
It was reported to boston scientific corporation that an ultratome xl was in the duodenum during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2019.According to the complainant, during the procedure, the orientation of catheter tip and cutting wire were incorrect.The procedure was completed with a second ultratome xl.There were no patient complications reported as a result of this event.
 
Manufacturer Narrative
Block d4, h4: the complainant was unable to report the lot number; therefore the manufacture date and expiration date are unknown.Block h6 (device codes): problem code 3009 captures the reportable event of cutting wire orientation.Block h10: visual analysis of the returned device found in good conditions.Functionally, the device was introduced inside the duodenoscope, and the cutting wire position was found within the specifications.Based on all compiled information on this investigation, the most probable cause is no problem detected since the complaint included a returned device review which showed no evidence of either the alleged issue or any defect which could have contributed to the event.
 
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Brand Name
ULTRATOME XL
Type of Device
SNARE, FLEXIBLE
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
300 boston scientific way
marlborough MA 01752
MDR Report Key8596094
MDR Text Key144723983
Report Number3005099803-2019-02442
Device Sequence Number1
Product Code FDI
UDI-Device Identifier08714729103257
UDI-Public08714729103257
Combination Product (y/n)N
PMA/PMN Number
K930022
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 07/01/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/09/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberM00535900
Device Catalogue Number3590
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/08/2019
Date Manufacturer Received06/07/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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