MAUDE Adverse Event Report: BOSTON SCIENTIFIC - SPENCER TRAPEZOID¿ RX; LITHOTRIPTOR, BILIARY MECHANICAL

Model Number M00510880

Device Problem Separation Failure (2547)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/29/2018

Event Type  Injury  

Manufacturer Narrative

Device component code relates to device problem code for the reported event of tip won¿t detach.A visual evaluation of the returned device found that only one section of the wire assembly was returned for inspection, the handle part of the device was not returned.The returned part of the wire assembly was cut at its proximal section, the tip was found properly attached to the basket with no evidence of defects; however, the basket is kinked/bent.The device was used to capture a stone of ¿around 13.4mm¿, however the device is designed for calculus larger than 1.5 cm (15 mm), this could have caused the reported failure tip wont detached since the stone involved within the procedure was smaller and the force applied to the basket in order to allow the tip to be detached could have been insufficient taking into consideration that the basket is bigger.The force applied to the device & attempts made to detach the basket tip may affect the basket section causing the encountered damage basket kinked/bent.The most probable root cause of the basket kinked/bent is operational context, since due to anatomical and/or procedural factors encountered during the procedure, performance was limited.The most probable cause for the reported event of tip won¿t detach is user error, since the complaint investigation determined that there was an act of omission that resulted in a different medical device response than intended by the manufacturer or expected by the user.The device history record (dhr) review found the device met all manufacturing specifications.A search of the complaint database revealed that no similar complaints exist for the specified lot.A product labeling review identified that the device was not used per the directions for use (dfu).

Event Description

It was reported to boston scientific corporation that a trapezoid¿ rx lithotripter basket was used in the common bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2018.According to the complainant, during the procedure, an alliance handle was used in conjunction with the trapezoid ¿ rx basket in an attempt to crush a 13.4 mm stone.However, the basket failed to crush the stone and the basket tip failed to detach.The handle of the trapezoid was then cut off with scissors to withdraw the scope.Sphincterotomy was then performed to insert forceps and bite one wire of the basket in order to release the stone.The basket was then removed and 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 ¿stable".

• Brand Name: TRAPEZOID¿ RX
• Type of Device: LITHOTRIPTOR, BILIARY MECHANICAL
• 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: 7301569
• MDR Text Key: 101115039
• Report Number: 3005099803-2018-00429
• Device Sequence Number: 1
• Product Code: LQC
• UDI-Device Identifier: 08714729296393
• UDI-Public: 08714729296393
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: K040447
• 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: 01/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/24/2018
• Device Model Number: M00510880
• Device Catalogue Number: 1088
• Device Lot Number: 21293198
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/02/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/29/2018
• Initial Date FDA Received: 02/27/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/24/2017
• 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): Required Intervention
• Patient Age: 67 YR
• Patient Weight: 110