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

Model Number M00510880

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/25/2019

Event Type  malfunction  

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 mdr will be filed.

Event Description

It was reported to boston scientific corporation that a trapezoid rx basket was used during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2019.According to the complainant, during lithotripsy, the accessory broke in the gauntlet region.The procedure was completed with another trapezoid rx basket.There were no patient complications reported as a result of this event.Boston scientific has been unable to obtain additional information regarding the event to date, despite good faith efforts.

Manufacturer Narrative

Block h6: problem code 1069 captures the reportable event of handle hannula broken.Block h10: the returned trapezoid rx was analyzed, and a visual evaluation noted that the working length was kinked/bent in several locations at the distal section.The handle cannula was found detached from the handle.Both dimples were visible on the handle cannula.Additionally, drag marks were present from the proximal and distal screw toward the proximal end of the cannula had been forcibly pulled out from the set screws.The distal screw and proximal screw depth were measured, and both were found within specification.The tip was still attached to the basket assembly.Based on all available information, the investigation concluded that procedural and anatomical factors encountered during the use of the device could have likely affected the device's performance and integrity.Handling and manipulation of the device during its use can lead to kinking/bending of the device.Kinks/bends in the working length can cause friction between the components during basket extension/retraction, this can cause more resistance in the handle to extend/retract the basket which would result in more force required to use the basket.Force applied to the handle can lead to the handle cannula detaching.Therefore, the most probable root cause is adverse event related to procedure.A review of the device history record (dhr) confirmed that the device met all material, assembly, and product specifications at the time of release to distribution.

Event Description

It was reported to boston scientific corporation that a trapezoid rx basket was used during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2019.According to the complainant, during lithotripsy, the accessory broke in the gauntlet region.The procedure was completed with another trapezoid rx basket.There were no patient complications reported as a result of this event.Boston scientific has been unable to obtain additional information regarding the event to date, despite good faith efforts.

• Brand Name: TRAPEZOID RX
• Type of Device: LITHOTRIPTOR, BILIARY MECHANICAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 9476262
• MDR Text Key: 183915620
• Report Number: 3005099803-2019-06103
• Device Sequence Number: 1
• Product Code: LQC
• UDI-Device Identifier: 08714729296393
• UDI-Public: 08714729296393
• 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: 10/29/2020

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: 03/03/2020
• Device Model Number: M00510880
• Device Catalogue Number: 1088
• Device Lot Number: 0023430245
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/09/2020
• Initial Date Manufacturer Received: 11/27/2019
• Initial Date FDA Received: 12/16/2019
• Supplement Dates Manufacturer Received: 10/05/2020
• Supplement Dates FDA Received: 10/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 37 YR