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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION AUTOTOME RX 44; UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)
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BOSTON SCIENTIFIC CORPORATION AUTOTOME RX 44; UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES) Back to Search Results
Model Number M00545170
Device Problems Break (1069); Device Dislodged or Dislocated (2923); Material Integrity Problem (2978)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 05/07/2019
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.
 
Event Description
It was reported to boston scientific corporation that an autotome rx 44 was used in the bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2019.According to the complainant, during unpacking, it was found that the tip was damaged.Additionally, the cutting wire broke and the wire anchor was dislodged from the catheter.The procedure was completed with a second autotome rx 44.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 stable.
 
Manufacturer Narrative
Block h6 (device codes): the problem code 2923 captures the reportable event of wire/anchor dislodged or dislocated.The problem code 1069 captures the reportable event of cutting wire broken.Block h10: visual examination of the returned device revealed that the device was found torn and the wire anchor was dislodged.Additionally, the cutting wire was found broken and blackened, which is evidence that the device was energized.According to the product analysis, the cutting wire of the returned product was found broken and blackened, so it is most likely that a peak of voltage could have caused the failures noted.It is important to mention that the dfu document states ''precaution: the sphincterotome does not need to be energized prior to performing sphincterotomy.Energizing the cutting wire prior to use will cause premature cutting wire fatigue and will compromise the cutting wire's integrity.'' the most probable cause of this failure is adverse event related to procedure since it is the most likely that the adverse event occurred during the procedure and the device had no influence on event.In addition, the received device has a torn distal pierced hole.This is evidence that the cutting wire anchor slipped out, causing the catheter to tear and the anchor wire to become dislodged.Based on this information, there is no evidence of a manufacturing issue related.This type of damage is associated with a known design limitation of the device generated by mechanical tear when the cutting wire/anchor is tearing through distal pierce hole and continuing down through the ptfe catheter.Therefore, the most probable cause for this complaint will be assigned as design inadequate for purpose, since the problems traced to design/design features of the device that do not support or interfere with the intended purpose of the device.There is an open investigation to address this issue.A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly and performance specifications at the time of release to distribution.
 
Event Description
It was reported to boston scientific corporation that an autotome rx 44 was used in the bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2019.According to the complainant, during unpacking, it was found that the tip was damaged.Additionally, the cutting wire broke and the wire anchor was dislodged from the catheter.The procedure was completed with a second autotome rx 44.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 stable.
 
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Brand Name
AUTOTOME RX 44
Type of Device
UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
300 boston scientific way
marlborough MA 01752
MDR Report Key8677028
MDR Text Key147308432
Report Number3005099803-2019-02925
Device Sequence Number1
Product Code KNS
UDI-Device Identifier08714729444749
UDI-Public08714729444749
Combination Product (y/n)N
PMA/PMN Number
K013153
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 07/03/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/06/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date09/02/2021
Device Model NumberM00545170
Device Catalogue Number4517
Device Lot Number0022600272
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/22/2019
Date Manufacturer Received06/12/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age67 YR
Patient Weight80
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