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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION AUTOTOME RX 49; UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)

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BOSTON SCIENTIFIC CORPORATION AUTOTOME RX 49; UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES) Back to Search Results
Model Number M00545150
Device Problem Break (1069)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/13/2022
Event Type  malfunction  
Manufacturer Narrative
(b)(4).The device has not been received for analysis.Upon receipt and completion of the device analysis, 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 that an autotome rx 49 was used in the common bile duct (cbd) during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2022.During the procedure, the cutting wire of the autotome rx 49 broke.It was reported that no part of the cutting wire detached and fell into the patient.The procedure was completed with another of the same device.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): medical device problem code a0401 captures the reportable event of cutting wire broken.Block h10: the returned autotome rx 49 was analyzed, and a visual evaluation noted that the cutting wire was broken, and it was not returned.The proximal end of the cutting wire was blackened.The distal tip of the working length was checked under magnification, and the proximal pierced hole was torn.Additionally, the unit was cut to check the anchor, and it was noted that the cutting wire was broken, and the anchor had remains of the cutting wire inside.No other problems with the device were noted.The reported event of cutting wire break was confirmed.Upon analysis, it was found that the cutting wire was broken, and blackened.The cutting wire being blackened indicates that the device was energized.Based on the condition of the device, the problem could have been generated if the device was energized prior to performing sphincterotomy, which can compromise the cutting wire's integrity, and premature cutting wire fatigue.Also, if there was contact between the device and the scope during energization or if the device exceeded the maximum of voltage during procedure as per precautions of the device states.Once the cutting wire breaks, and if the handle was actuated or any contact between the broken wire and the extrusion, it can tear the proximal pierced hole.Based on all gathered information, the most probable root cause of this complaint is adverse event related to procedure.A labeling review was performed and, from the information available, this device was used per the instructions for use (ifu) / product label.
 
Event Description
It was reported to boston scientific corporation that an autotome rx 49 was used in the common bile duct (cbd) during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2022.During the procedure, the cutting wire of the autotome rx 49 broke.It was reported that no part of the cutting wire detached and fell into the patient.The procedure was completed with another of the same device.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 49
Type of Device
UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
300 boston scientific way
marlborough MA 01752
Manufacturer (Section G)
BOSTON SCIENTIFIC CORPORATION
2546 calle primera
alajuela
CS  
Manufacturer Contact
carole morley
300 boston scientific way
marlborough, MA 01752
5086834015
MDR Report Key15152465
MDR Text Key304880604
Report Number3005099803-2022-04234
Device Sequence Number1
Product Code KNS
UDI-Device Identifier08714729415138
UDI-Public08714729415138
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K013153
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Health Professional,Company Representative,Distributor
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 10/26/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date07/02/2024
Device Model NumberM00545150
Device Catalogue Number4515
Device Lot Number0027605384
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 07/13/2022
Initial Date FDA Received08/02/2022
Supplement Dates Manufacturer Received10/03/2022
Supplement Dates FDA Received10/26/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/03/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Age50 YR
Patient SexMale
Patient Weight70 KG
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