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

Model Number M00510880

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/23/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Although the suspect device has been received, the evaluation has not been completed.Therefore, the cause of the reported malfunction has not been determined.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 trapezoid¿ rx basket was used in the common bile duct during endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2016.According to the complaint, during the procedure, an alliance handle was used in conjunction with the trapezoid¿ rx basket in an attempt to crush a 14mm stone.However, the handle cannula broke.An attempt to pull the device out of the patient was performed and the basket wire broke releasing the stone from the basket.A stent was implanted and the patient is scheduled for another ercp.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 examination of the returned device found the pull wire had been broken at proximal end and the handle cannula was not returned for analysis.Additionally, the pullwire was found bent.The basket tip was found intact and one of the basket wires was broken.The broken ends of the basket wire were discolored and consistent with those that were contacted by laser.Stone size and density, user technique, tortuous anatomy and other procedural factors could possibly contribute to the failures by causing the tensile force applied by the user to not be fully distributed throughout the device.However, it cannot be determined precisely how the pull wire and the tip failed since only the wire basket assembly was received and the handle cannula was not returned.Therefore, the most probable root cause of "undeterminable" is selected for the complaint.The device history record review found the device met all manufacturing specifications.A search of the complaint database revealed that no similar complaints exist for the specified lot.

Event Description

It was reported to boston scientific corporation that a trapezoid¿ rx basket was used in the common bile duct during endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2016.According to the complaint, during the procedure, an alliance handle was used in conjunction with the trapezoid¿ rx basket in an attempt to crush a 14mm stone.However, the handle cannula broke.An attempt to pull the device out of the patient was performed and the basket wire broke releasing the stone from the basket.A stent was implanted and the patient is scheduled for another ercp.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: 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: 6176231
• MDR Text Key: 62546353
• Report Number: 3005099803-2016-03824
• Device Sequence Number: 1
• Product Code: LQC
• UDI-Device Identifier: 08714729296393
• UDI-Public: (01)08714729296393(17)20170804(10)19556003
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K040447
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/23/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/04/2017
• Device Model Number: M00510880
• Device Catalogue Number: 1088
• Device Lot Number: 19556003
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/02/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/23/2016
• Initial Date FDA Received: 12/15/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/06/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/05/2016
• 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