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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 M00545180
Device Problems Failure to Fold (1255); Material Integrity Problem (2978); Positioning Problem (3009)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/01/2021
Event Type  malfunction  
Manufacturer Narrative
Patient's exact age is unknown; however, it was reported that the patient was over the age of 18.The exact date of the event is unknown.The provided event date (b)(6) 2021 was chosen as a best estimate based on the date that the manufacturer became aware of the event.(b)(6).(b)(4).The device has been received for analysis; however, the analysis has not yet been completed.Upon completion of the problem 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 that an autotome rx 44 was used in the papilla during an endoscopic retrograde cholangiopancreatography (ercp) procedure.The exact procedure date was unknown.During the procedure, it was noticed that the cutting wire had an unusual direction.It was also reported that the handle seemed locked and the device unable to bow.The procedure was completed with another of the same device.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.The reported event may suggest that the cutting wire orientation was incorrect.
 
Event Description
It was reported to boston scientific corporation that an autotome rx 44 was used in the papilla during an endoscopic retrograde cholangiopancreatography (ercp) procedure.The exact procedure date was unknown.During the procedure, it was noticed that the cutting wire had an unusual direction.It was also reported that the handle seemed locked and the device unable to bow.The procedure was completed with another of the same device.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.The reported event may suggest that the cutting wire orientation was incorrect.
 
Manufacturer Narrative
Block a2: patient's exact age is unknown; however, it was reported that the patient was over the age of 18.Block b3: the exact date of the event is unknown.The provided event date 01oct2021 was chosen as a best estimate based on the date that the manufacturer became aware of the event.Section e: this event was reported by the distributor.The physician is: (b)(6) block h6 (device codes): medical device problem code a1502 captures the reportable event of incorrect cutting wire orientation.Block h10: the returned autotome rx 44 was analyzed, and a visual evaluation noted that the working length was twisted at the distal section and the guidewire introducer was cracked.The cracked area of the guidewire introducer was observed under magnification and there was a whitened area opposite from the cracked section, indicating that likely the component was submitted to tension forces.A functional evaluation was performed by introducing the device into the scope and when the distal tip exited the scope, it was found that the wire was out of specifications due to the twist.The device was able to rotate without any problem.Additionally, bowing test was performed both outside and inside the scope and the device bowed and unbowed as intended.No other problems with the device were noted.The reported complaint of wire incorrect orientation was confirmed.Upon analysis, it was found that the working length was twisted at the distal section which could have caused the orientation of the cutting wire to be out of specifications.Based on the condition of the device, working length could twist upon multiple attempts to rotate the handle or due to the interaction with the endoscope while advancing it.The cause of these problems are operational factors in the rotation of the device.Based on all gathered information, the most probable root cause of this complaint is adverse event related to procedure.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.
 
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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
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 Key12778951
MDR Text Key284639896
Report Number3005099803-2021-05739
Device Sequence Number1
Product Code KNS
UDI-Device Identifier08714729444756
UDI-Public08714729444756
Combination Product (y/n)N
Reporter Country CodeJA
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 Other
Type of Report Initial,Followup
Report Date 12/13/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/09/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberM00545180
Device Catalogue Number4518
Device Lot Number0027604635
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/05/2021
Is the Reporter a Health Professional? No
Date Manufacturer Received11/19/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/02/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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