MAUDE Adverse Event Report: BOSTON SCIENTIFIC - COSTA RICA (COYOL) AUTOTOME¿ RX 44; UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)

Model Number M00545180

Device Problem Break (1069)

Patient Problems No Consequences Or Impact To Patient (2199); Device Embedded In Tissue or Plaque (3165)

Event Date 11/14/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).A visual and functional inspection for the complaint device could not be performed as the device was disposed and not returned for analysis.The device history record review was performed and no deviation was found.Labeling review was performed and no anomalies were found.Based on the available information, most likely, the defect was due to anatomical/procedural factors encountered during the procedure, therefore, the probable cause conclusion for the complaint is operational context.

Event Description

It was reported to boston scientific corporation that an autotome rx 44 device was used in the ampulla of the distal common bile duct during an endoscopic retrograde cholangiopancreatography procedure performed on (b)(6) 2017.According to the complainant, during the procedure, while performing sphincterotomy, the cutting wire detached inside the patient.The detached cutting wire was unable to be retrieved.Reportedly, the physician was concerned about the unretrieved cutting wire.The procedure was completed with another autotome rx 44.There were no patient complications reported as a result of this event.

• Brand Name: AUTOTOME¿ RX 44
• Type of Device: UNIT, 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 Key: 7122228
• MDR Text Key: 94998832
• Report Number: 3005099803-2017-03692
• Device Sequence Number: 1
• Product Code: KNS
• UDI-Device Identifier: 08714729444756
• UDI-Public: 08714729444756
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K013153
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/20/2020
• Device Model Number: M00545180
• Device Catalogue Number: 4518
• Device Lot Number: 20796174
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/15/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/21/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention