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

Model Number M00510890

Device Problem Separation Failure (2547)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/01/2023

Event Type  malfunction  

Manufacturer Narrative

The exact date of the event is unknown.The provided event date was chosen as a best estimate based on the date that the manufacturer became aware of the event.Imdrf device code a150301 captures the reportable event of tip failure to separate.

Event Description

It was reported to boston scientific corporation that a trapezoid rx basket was used in the biliary duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on unknown date.During the procedure, an alliance ii handle was used in conjunction with the trapezoid basket to crush a stone.However, the tip did not separate from the basket, trapping the stone.With the stone still inside the basket, the physician shook the basket until the stone was released.The procedure was completed using a spyglass and a laser.There were no patient complications reported as a result of this event.

Event Description

It was reported to boston scientific corporation that a trapezoid rx basket was used in the biliary duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on unknown date.During the procedure, an alliance ii handle was used in conjunction with the trapezoid basket to crush a stone.However, the tip did not separate from the basket, trapping the stone.With the stone still inside the basket, the physician shook the basket until the stone was released.The procedure was completed using a spyglass and a laser.There were no patient complications reported as a result of this event.

Manufacturer Narrative

Block b3: the exact date of the event is unknown.The provided event date was chosen as a best estimate based on the date that the manufacturer became aware of the event.Block h6: imdrf device code a150301 captures the reportable event of tip failure to separate.Block h10: the returned trapezoid rx basket was analyzed, and a visual evaluation noted that the sidecar rx was pushed back out of specification.Dimensional inspection observed the side car rx was pushed back approximately 3 mm which is out of specification.Functional inspection was performed, and the basket came out and retracted without problems.Therefore, the reported complaint of "tip failure to separate" is not confirmed.The reported event was not confirmed.Based on all available information, it is possible that the manipulation or technique applied during the procedure may have caused the side car rx being pushed back.Therefore, this issue will be documented as an unreported allegation, and the assigned cause code is "adverse event related to procedure.".

• 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: 16632427
• MDR Text Key: 312196779
• Report Number: 3005099803-2023-01622
• Device Sequence Number: 1
• Product Code: LQC
• UDI-Device Identifier: 08714729296409
• UDI-Public: 08714729296409
• Combination Product (y/n): N
• Reporter Country Code: CS
• PMA/PMN Number: K040447
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 06/12/2023

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: 09/15/2021
• Device Model Number: M00510890
• Device Catalogue Number: 1089
• Device Lot Number: 0026021267
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/07/2023
• Initial Date FDA Received: 03/28/2023
• Supplement Dates Manufacturer Received: 05/24/2023
• Supplement Dates FDA Received: 06/12/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/15/2020
• 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