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

Model Number M00510870

Device Problem Separation Failure (2547)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/01/2020

Event Type  malfunction  

Manufacturer Narrative

Patient's exact age is unknown; however it was reported that the patient was over the age of 18.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.The complainant was unable to provide the suspect device lot number, therefore, the lot expiration and device manufacture dates are unknown.However, the complainant reported that the device was not expired.(b)(4).According to the complainant, the suspect device has been disposed and is not available for return.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 basket was used in the bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on an unknown date.According to the complainant, during the procedure, an alliance ii handle was used in conjunction with the trapezoid basket in an attempt to crush a stone.However, the basket failed to crush the stone.Additionally, the tip failed to separate from the basket to release the stone.With the stone still inside the basket, the physician managed to pull the basket out of the bile duct.The procedure was completed with the original device.There were no patient complications reported as a result of this event.

• 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: 10707711
• MDR Text Key: 212576774
• Report Number: 3005099803-2020-04812
• Device Sequence Number: 1
• Product Code: LQC
• UDI-Device Identifier: 08714729296386
• UDI-Public: 08714729296386
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K040447
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/20/2020

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 Model Number: M00510870
• Device Catalogue Number: 1087
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/24/2020
• Initial Date FDA Received: 10/20/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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