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

Model Number M00510890

Device Problems Separation Failure (2547); Defective Device (2588)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/12/2018

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 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 stone.However, stone was unable to be crushed and the tip of the basket failed to detach to release the stone.As a result, the device was removed with the stone still trapped inside the basket.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".

Event Description

It was reported to boston scientific corporation that a trapezoid rx 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 stone.However, stone was unable to be crushed and the tip of the basket failed to detach to release the stone.As a result, the device was removed with the stone still trapped inside the basket.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".

Manufacturer Narrative

Visual evaluation of the returned trapezoid basket revealed that the working length was kinked and bent in several locations, including the distal section.The thumb ring was smashed and the unit presented a pushback out of specification.Functional analysis revealed that the basket could be extended but with resistance due to the damages found on the device.The basket could be retracted without issues.The basket tip was intact and attached to the basket.The basket wires were found bent and kinked.It is most likely that procedural factors encountered during the procedure could have affected the device performance and its integrity.Likely the failures found (working length kinked/bent, side car pushback, thumb ring smashed, basket wires bent/kinked and difficulty to extend) are issues that could have been generated by excessive manipulation of the device by the user, the interacting with the scope or with other devices.These failures, working length and basket wires kinked/bent, could directly impacted/limited the functionality of the unit to the extent that it will be unable to crush the stone and disengage the tip of the basket.Therefore taking into consideration all this factors and the condition of the returned device, the most probable cause of this complaint is "operational context", since it is most likely that due to anatomical and/or procedural factors encountered during the procedure the performance of the device was limited.A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly, and performance specifications at the time of release for distribution.A search of the complaint database revealed that no other complaints exist for the specified lot.

• Brand Name: TRAPEZOID¿ RX
• Type of Device: LITHOTRIPTOR, BILIARY MECHANICAL
• Manufacturer (Section D): BOSTON SCIENTIFIC - SPENCER; 780 brookside drive; spencer IN 47460
• MDR Report Key: 7736042
• MDR Text Key: 115650317
• Report Number: 3005099803-2018-02505
• Device Sequence Number: 1
• Product Code: LQC
• UDI-Device Identifier: 08714729296409
• UDI-Public: 08714729296409
• Combination Product (y/n): N
• PMA/PMN Number: K040447
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 07/12/2018

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: 04/03/2019
• Device Model Number: M00510890
• Device Catalogue Number: 1089
• Device Lot Number: 21940143
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/23/2018
• Initial Date Manufacturer Received: 07/12/2018
• Initial Date FDA Received: 07/31/2018
• Supplement Dates Manufacturer Received: 08/20/2018
• Supplement Dates FDA Received: 09/13/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 56 YR