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

Model Number M00510860

Device Problem Separation Failure (2547)

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

Event Date 10/28/2021

Event Type  malfunction  

Event Description

It was reported to boston scientific corporation that a trapezoid rx basket was used in the wirsung duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2021.During the procedure, an alliance ii handle was used in conjunction with the trapezoid basket in an attempt to crush a stone less than 1 cm in size.However, the basket failed to crush the stone and the tip of the basket did not detach to release the stone.The device was pulled several times until the basket came out of the wirsung duct.There was no medical/ surgical intervention and the procedure was completed with another trapezoid rx basket.There were no patient complications reported as a result of this event.Note: the complainant reported that the trapezoid rx basket was used in the wirsung (pancreatic) duct; however, the directions for use state "caution: trapezoid rx wireguided retrieval basket is not intended for use in the pancreas.".

Manufacturer Narrative

Patient's exact age is unknown; however it was reported that the patient was over the age of 18.(b)(4).According to the complainant, the suspect device was contaminated and is not available for return.If any further relevant information is received, a supplemental medwatch will be filed.

• 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: 12855919
• MDR Text Key: 286021332
• Report Number: 3005099803-2021-05921
• Device Sequence Number: 1
• Product Code: LQC
• UDI-Device Identifier: 08714729296379
• UDI-Public: 08714729296379
• Combination Product (y/n): N
• Reporter Country Code: SP
• 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: Physician
• Type of Report: Initial
• Report Date: 11/22/2021

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
• Device Expiration Date: 06/03/2022
• Device Model Number: M00510860
• Device Catalogue Number: 1086
• Device Lot Number: 0027431034
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/28/2021
• Initial Date FDA Received: 11/22/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/03/2021
• 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
• Patient Sex: Female