MAUDE Adverse Event Report: BOSTON SCIENTIFIC - SPENCER TRUETOME¿ 44; UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)

Model Number M00584180

Device Problem No Apparent Adverse Event (3189)

Patient Problem Inflammation (1932)

Event Date 08/30/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).Patient's exact age is unknown; however it was reported that the patient was over the age of 18.The exact patient¿s weight is unknown; however, it was reported that the patient is around (b)(6) at the time of the event.(b)(4).A visual examination of the returned device found no issues with the cutting wire and the working length.Functionally, the device bowed more than 90 degrees both inside and outside the duodenoscope.In addition, the resistance was found within specifications.The complaint was not confirmed since the condition of the returned device could not be functionally evaluated with respect to the procedural factors encountered during the procedure ¿pancreatitis¿.Pancreatitis as an anticipated procedural complication and it is noted within the adverse events section of the device dfu, therefore, the most probable root cause for the complaint is anticipated procedural complication.A dhr (device history record) review was performed and no deviation was found.A search of the complaint database confirmed that no similar complaints exist for the specified batch.A labeling review was performed and there is no evidence that the device was not used in accordance with the labeling.

Event Description

It was reported to boston scientific corporation that a truetome was used in the sphincter of oddi during a sphincterotomy procedure performed on (b)(6) 2016.According to the complainant, during the procedure, when the physician attempted to incise the papilla, it was noticed that the device could not cut.The generator setting was checked; however, it was noticed that the device could only cauterize but still could not cut.The procedure was not completed due to this event.Reportedly, the patient had mild pancreatitis and there were no interventions performed for mild pancreatitis.In the physician's assessment, the pancreatitis was caused by the sphincterotomy procedure.The patient's condition at the conclusion of the procedure was reported to be stable.

• Brand Name: TRUETOME¿ 44
• Type of Device: UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)
• Manufacturer (Section D): BOSTON SCIENTIFIC - SPENCER; 780 brookside drive; spencer IN 47460
• Manufacturer (Section G): BOSTON SCIENTIFIC - SPENCER; 780 brookside drive; spencer IN 47460
• Manufacturer Contact: nancy cutino ; 100 boston scientific way; marlborough, MA 01752 ; 5086834000
• MDR Report Key: 5978125
• MDR Text Key: 55669140
• Report Number: 3005099803-2016-02951
• Device Sequence Number: 1
• Product Code: KNS
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: K122203
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/30/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/26/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 05/31/2018
• Device Model Number: M00584180
• Device Catalogue Number: 8418
• Device Lot Number: 0019294447
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/05/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/30/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/27/2016
• 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