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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC - MARLBOROUGH ACCUTRAC (TM) SINGLE-USE HOLMIUM LASER FIBER; POWERED LASER SURGICAL INSTRUMENT
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BOSTON SCIENTIFIC - MARLBOROUGH ACCUTRAC (TM) SINGLE-USE HOLMIUM LASER FIBER; POWERED LASER SURGICAL INSTRUMENT Back to Search Results
Model Number M0068404112
Device Problem Bent (1059)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 04/19/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4).The device has been received for analysis; however 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 medwatch will be filed.
 
Event Description
It was reported to boston scientific corporation on (b)(6) 2018 that an accutrac 200 laser fiber was used during a ureteroscopy procedure in the ureter and kidney performed on (b)(6) 2018.According to the complainant, during the procedure and inside the patient, the laser fiber was used for 45 seconds and it was noted that the glass tip was bent.The procedure was completed with another accutrac 200 laser fiber.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 fine.
 
Manufacturer Narrative
One accutrac 200 laser fiber was received for evaluation.Visual examination revealed that there was no exposed glass fiber tip remaining.Additional examination under magnification revealed that the pattern on the tip face was consistent with a fracture indicating that the tip or portion of the tip broke off.There was a burn mark at the break.The noted damages indicate difficulty was experienced during the procedure and are likely due to anatomical or procedural factors such as tortuous anatomy or maneuvering of the device.Therefore, a review and analysis of all available information indicated that the most probable root cause is operational context.A review of the device history record (dhr) was performed; no anomalies were noted.A search of the complaint database revealed that no similar complaints exist for the specified lot.
 
Event Description
It was reported to boston scientific corporation on (b)(6) 2018 that an accutrac 200 laser fiber was used during a ureteroscopy procedure in the ureter and kidney performed on (b)(6) 2018.According to the complainant, during the procedure and inside the patient, the laser fiber was used for 45 seconds and it was noted that the glass tip was bent.The procedure was completed with another accutrac 200 laser fiber.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 fine.
 
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Brand Name
ACCUTRAC (TM) SINGLE-USE HOLMIUM LASER FIBER
Type of Device
POWERED LASER SURGICAL INSTRUMENT
Manufacturer (Section D)
BOSTON SCIENTIFIC - MARLBOROUGH
100 boston scientific way
marlborough MA 01752
Manufacturer Contact
nancy cutino
100 boston scientific way
marlborough, MA 01752
5086834000
MDR Report Key7480102
MDR Text Key107282601
Report Number3005099803-2018-01436
Device Sequence Number1
Product Code GEX
UDI-Device Identifier08714729802709
UDI-Public08714729802709
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K110686
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 04/19/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/02/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date03/02/2021
Device Model NumberM0068404112
Device Catalogue Number840-411
Device Lot Number0000005725
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/26/2018
Is the Reporter a Health Professional? Yes
Date Manufacturer Received05/25/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/02/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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