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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC - COSTA RICA (COYOL) AUTOTOME¿ RX 39 UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)

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BOSTON SCIENTIFIC - COSTA RICA (COYOL) AUTOTOME¿ RX 39 UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES) Back to Search Results
Model Number M00545190
Device Problems Wire (430); Break (1069)
Patient Problem Electric Shock (2554)
Event Date 11/27/2017
Event Type  Injury  
Manufacturer Narrative

Although the suspect device has been received, the evaluation has not been completed. 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 a autotome rx 39 device was used in the common bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2017. According to the complainant, during the procedure, while performing sphincterotomy, when the current was applied, the cutting wire broke and the patient jolted. Reportedly, no part of the device detached inside the patient. The procedure was completed with a different 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 fine.

 
Manufacturer Narrative

Visual evaluation of the returned device found that the cutting wire was bent, broken and blackened. Additionally, the working length was twisted. The investigation concluded that the cutting wire was bent, broken, and blackened, so it is most likely that a peak of voltage during the procedure could cause the failures noted. Moreover, the twisted section is a known failure which could have been generated due to the device manipulation. Based on the investigation and the receipt condition/functionality, the complaint conclusion investigation code selected for the complaint of cutting wire broken is operational context since due to anatomical/procedural factors encountered during the procedure, performance was limited. 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. A labeling review was performed and no anomaly was found.

 
Event Description

It was reported to boston scientific corporation that a autotome rx 39 device was used in the common bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2017. According to the complainant, during the procedure, while performing sphincterotomy, when the current was applied, the cutting wire broke and the patient jolted. Reportedly, no part of the device detached inside the patient. The procedure was completed with a different 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 fine.

 
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Brand NameAUTOTOME¿ RX 39
Type of DeviceUNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)
Manufacturer (Section D)
BOSTON SCIENTIFIC - COSTA RICA (COYOL)
2546 first street
propark free zone
alajuela
CS
Manufacturer (Section G)
BOSTON SCIENTIFIC - COSTA RICA (COYOL)
2546 first street
propark free zone
alajuela
CS
Manufacturer Contact
nancy cutino
100 boston scientific way
marlborough, MA 01752
5086834000
MDR Report Key7143913
MDR Text Key95670880
Report Number3005099803-2017-03774
Device Sequence Number1
Product Code KNS
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK013153
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial,Followup
Report Date 11/27/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/22/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date03/22/2020
Device MODEL NumberM00545190
Device Catalogue Number4519
Device LOT Number0020442185
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer12/01/2017
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/05/2018
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured03/24/2017
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 12/22/2017 Patient Sequence Number: 1
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