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 CORPORATION FLEXIVA; LITHOTRIPTOR, BILIARY MECHANICAL
  • 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 CORPORATION FLEXIVA; LITHOTRIPTOR, BILIARY MECHANICAL Back to Search Results
Device Problem Break (1069)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/02/2020
Event Type  malfunction  
Manufacturer Narrative
The complainant was unable to provide the suspect device upn and lot number.Therefore, the lot expiration and device manufacture dates are unknown.(b)(4).The complainant indicated that the device is not available for return; 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 Description
It was reported to boston scientific corporation on (b)(6) 2020 that a flexiva laser fiber was used in a laser lithotripsy procedure for stones performed on (b)(6) 2020.According to the complainant, the laser fiber was broken.There were no patient complications reported as a result of this event.Boston scientific has been unable to obtain additional information regarding the event to date, despite good faith efforts.
 
Manufacturer Narrative
Block d4, h4: the complainant was unable to provide the suspect device upn and lot number.Therefore, the lot expiration and device manufacture dates are unknown.Block h2: additional information: block b5.Block h6: problem code 1069 captures the reportable event of fiber break.Block h10: the complainant indicated that the device is not available for return; 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 Description
It was reported to boston scientific corporation on (b)(6) 2020 that a flexiva laser fiber was used in a laser lithotripsy procedure for stones performed on (b)(6) 2020.According to the complainant, the laser fiber was broken.There were no patient complications reported as a result of this event.Boston scientific has been unable to obtain additional information regarding the event to date, despite good faith efforts.Additional information received on (b)(6) 2020: the complaint device was not a fiber; the correct device that was broken was a basket.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
FLEXIVA
Type of Device
LITHOTRIPTOR, BILIARY MECHANICAL
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
300 boston scientific way
marlborough MA 01752
MDR Report Key10344064
MDR Text Key202375709
Report Number3005099803-2020-03043
Device Sequence Number1
Product Code LQC
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 08/27/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/30/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Was Device Available for Evaluation? No
Date Manufacturer Received08/03/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
-
-