MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION TRAPEZOID RX; LITHOTRIPTOR, BILIARY MECHANICAL

Model Number 1088

Device Problems Break (1069); Mechanical Problem (1384)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/24/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).The device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.

Event Description

It was reported to boston scientific corporation that a trapezoid rx lithotripter basket was used during an endoscopic retrograde cholangiopancreatography (ercp) in the common bile duct (cbd) on (b)(6) 2020.According to the complainant, during the procedure, post sphincterotomy a stone was unable to be removed due to the size of the stone.A lithotripter basket was then used in an attempt to crush the stone.The stone was unable to be crushed by hand with the trapezoid basket.Therefore an alliance 2 handle was used in conjunction with the trapezoid basket for mechanical lithotripsy.However, a breaking sound was heard before the maximum tension was achieved.Upon removal of the trapezoid from the alliance 2 handle, it was noted that the break occurred in the wire mechanism between the handle and the basket.The physician decided to use the emergency lithotripsy mechanism available (medworks) and cut the trapezoid basket below the handle.The outer metal sheath on the trapezoid could not be removed to allow the inner wires to pass through the emergency lithotripsy mechanism.Emergency lithotripsy was unsuccessful so they decided to leave the remaining trapezoid inside the patient and transfer the patient to the hepato-pancreatico-biliary (hpb) team at queens medical centre (qmc) in nottingham, england.At this point, the physician used their emergency lithotripter kit (olympus) to break the basket endoscopically.The basket was removed from the patient.The stone was not removed with the basket.There were no patient complications reported as a result of this event.The patient's condition was reported to be fine.Another ercp is scheduled as the patient had several stones that required removal.

• Brand Name: TRAPEZOID RX
• Type of Device: LITHOTRIPTOR, BILIARY MECHANICAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 780 brookside drive; spencer IN 47460
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 9847434
• MDR Text Key: 189600780
• Report Number: 3005099803-2020-00885
• Device Sequence Number: 1
• Product Code: LQC
• UDI-Device Identifier: 08714729296393
• UDI-Public: 08714729296393
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K040447
• 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
• Report Date: 03/18/2020

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: 06/06/2020
• Device Model Number: 1088
• Device Catalogue Number: 1088
• Device Lot Number: 0023916528
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/24/2020
• Initial Date FDA Received: 03/18/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/07/2019
• 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