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

Model Number M00510890

Device Problems Separation Failure (2547); Difficult to Open or Close (2921)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 12/06/2019

Event Type  malfunction  

Manufacturer Narrative

The complainant was unable to report the upn and lot number; therefore the manufacture date and expiration date are unknown.(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 a procedure performed on (b)(6) 2019.According to the complainant, the ball tip part of the basket failed to dislodge.There were no known 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 h2: blocks a1, a2, a3, b5, d4, h4 and h6 have been updated based on additional information received on (b)(6)2020.Block h6: problem code 2547 captures the reportable event of tip failure to separate.Block h10: the complainant indicated that the device was disposed and will not be returned for evaluation; therefore, a failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental mdr will be filed.

Event Description

It was reported to boston scientific corporation that a trapezoid rx basket was used during a procedure performed on (b)(6) 2019.According to the complainant, the ball tip part of the basket failed to dislodge.There were no known 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.***additional information received on (b)(6), 2020*** the complainant reported that, during the procedure, an alliance handle was used in conjunction with trapezoid basket to crush a stone which was less than 2cm in size in the common bile duct.Initially, there was difficulty closing the basket and the tip failed to dislodge.However, the stone was eventually able to be removed from the basket, and the basket was then removed from the patient through the duodenoscope.There were no patient complications reported as a result of this event.The patient's condition post procedure was reported to be okay.

• 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: 9569085
• MDR Text Key: 189901498
• Report Number: 3005099803-2019-06472
• Device Sequence Number: 1
• Product Code: LQC
• 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,health
• Type of Report: Initial,Followup
• Report Date: 02/03/2020

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: 10/17/2020
• Device Model Number: M00510890
• Device Catalogue Number: 1089
• Device Lot Number: 0024622044
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/12/2019
• Initial Date FDA Received: 01/09/2020
• Supplement Dates Manufacturer Received: 01/09/2020
• Supplement Dates FDA Received: 02/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 87 YR