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

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/01/2020

Event Type  malfunction  

Manufacturer Narrative

The complainant was unable to clarify the basket name or the device upn and lot number; therefore the manufacture date and expiration date are unknown, and the product type was selected based on the limited information provided.(b)(6).(b)(4).The basket device has not been received by boston scientific corporation to date.If any further relevant information is received, a supplemental mdr will be filed.

Event Description

It was reported to boston scientific corporation that a trapezoid rx lithotripter basket was used in the common bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2020.According to the complainant, during the procedure, after endoscopic sphincterotomy was performed, an alliance handle was used in conjunction with the basket to crush a stone.However, the handle cannula detached, and the basket became stuck inside the patient.An olympus lithocrush was then used but failed to crush the stone.The stones were successfully crushed using an "end tripter," and the procedure was completed.Boston scientific has been unable to obtain additional information regarding the event to date, despite good faith efforts.There were no patient complications as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.

Manufacturer Narrative

Block b5, d4, h4: at the time the initial report was sent, the complainant was not able to clarify the basket name.Trapezoid rx lithotripter basket was chosen based on the limited information provided.However, on (b)(6) 2021, additional information was received that the correct complaint device used was a stonesmash lithotripter basket.Block e1: initial reporter facility name: (b)(6) block h2: additional information: block b5 block h6: device code 2907 captures the reportable event of handle cannula detached.Block h10: the basket device has not been received by boston scientific corporation to date.If any further relevant information is received, a supplemental mdr will be filed.

Event Description

It was reported to boston scientific corporation that a trapezoid rx lithotripter basket was used in the common bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6), 2020.According to the complainant, during the procedure, after endoscopic sphincterotomy was performed, an alliance handle was used in conjunction with the basket to crush a stone.However, the handle cannula detached, and the basket became stuck inside the patient.An olympus lithocrush was then used but failed to crush the stone.The stones were successfully crushed using an "end tripter," and the procedure was completed.Boston scientific has been unable to obtain additional information regarding the event to date, despite good faith efforts.There were no patient complications as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.***additional information received on (b)(6) 2021*** the correct complaint device used was a stonesmash litho basket, and the device used to complete the procedure was an endtripter (non-bsc device).

• 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: 11100289
• MDR Text Key: 225327252
• Report Number: 3005099803-2020-06481
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 01/27/2021

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
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/03/2020
• Initial Date FDA Received: 12/31/2020
• Supplement Dates Manufacturer Received: 01/04/2021
• Supplement Dates FDA Received: 01/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1