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

Model Number M00510860

Device Problems Use of Device Problem (1670); Separation Failure (2547)

Patient Problem No Code Available (3191)

Event Date 11/06/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).According to the complainant, the suspect device 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 pancreatic duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2019.According to the complainant, during the procedure, a trapezoid basket was used in conjunction with an alliance handle in an attempt to crush a 9mm size stone.However, the basket failed to crush the stone and the tip did not detach.The handle was cut from the device and an apc circumferential probe was used to cut the basket wire within the patient's duodenum.The basket remained in the pancreatic duct and a pancreatic stent was placed alongside the basket.The patient was discharged with plans to schedule a spyglass procedure to remove the basket a few weeks later.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.The complainant reported that the trapezoid rx basket was used in the pancreatic duct; however, the directions for use state "caution: trapezoid rx wireguided retrieval basket is not intended for use in the pancreas.".

• 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: 9395238
• MDR Text Key: 168614232
• Report Number: 3005099803-2019-05827
• Device Sequence Number: 1
• Product Code: LQC
• UDI-Device Identifier: 08714729296379
• UDI-Public: 08714729296379
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K040447
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/20/2020
• Device Model Number: M00510860
• Device Catalogue Number: 1086
• Device Lot Number: 0024469657
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/06/2019
• Initial Date FDA Received: 12/02/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/21/2019
• 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 Outcome(s): Required Intervention
• Patient Age: 68 YR
• Patient Weight: 91