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

Model Number M00545190

Device Problem 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.

• Brand Name: AUTOTOME¿ RX 39
• 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: 7143913
• MDR Text Key: 95670880
• Report Number: 3005099803-2017-03774
• Device Sequence Number: 1
• Product Code: KNS
• UDI-Device Identifier: 08714729444763
• UDI-Public: 08714729444763
• 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,Followup
• Report Date: 11/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/22/2020
• Device Model Number: M00545190
• Device Catalogue Number: 4519
• Device Lot Number: 0020442185
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/01/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/05/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/24/2017
• 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): Other