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U.S. Department of Health and Human Services

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

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BOSTON SCIENTIFIC - COSTA RICA (COYOL) AUTOTOME RX SPHINCTEROTOME UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES) Back to Search Results
Model Number UNK24
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Perforation (2001)
Event Date 09/21/2016
Event Type  Injury  
Manufacturer Narrative

The complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown. However, the complainant reported that the device was not expired. The complainant indicated that the device was disposed and will not be returned for evaluation; therefore, a failure analysis of the complaint device could not be completed. If any further relevant information is identified, a supplemental medwatch will be filed.

 
Event Description

It was reported to boston scientific corporation that either a dreamtome or a hydratome sphincterotome was used during a endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2016. According to the complainant, during the procedure, after sphincterotomy of the ampulla, free air was seen on the fluoroscopy image. It was determined that a perforation occurred in the ampulla during the sphincterotomy. As a result, the ercp procedure was not completed, and the patient was sent to interventional radiology (ir) to perform the biliary drainage. According to the physician, the patient recovered after the procedure.

 
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Brand NameAUTOTOME RX SPHINCTEROTOME
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 Key6216629
MDR Text Key63687540
Report Number3005099803-2016-04055
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
Report Date 12/07/2016
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/30/2016
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberUNK24
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/07/2016
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
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: 12/30/2016 Patient Sequence Number: 1
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