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

Model Number M00510880

Device Problem Entrapment of Device (1212)

Patient Problem No Code Available (3191)

Event Date 04/04/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).The complainant indicated that the device will not be returned for evaluation; therefore, a failure analysis of the complaint device could not be completed.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 a procedure performed on (b)(6) 2019.According to the complainant, during the procedure, the trapezoid basket was stuck in the patient's biliary tract and required surgical intervention.Reportedly, exploratory surgery with cholecystectomy was then performed.Attempts to obtain additional information regarding this event have been unsuccessful to date.Should additional relevant details become available, a supplemental report will be submitted.

• 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: 8755111
• MDR Text Key: 149847820
• Report Number: 3005099803-2019-03328
• Device Sequence Number: 1
• Product Code: LQC
• UDI-Device Identifier: 08714729296393
• UDI-Public: 08714729296393
• Combination Product (y/n): N
• PMA/PMN Number: K040447
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial
• Report Date: 07/02/2019

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: 11/12/2019
• Device Model Number: M00510880
• Device Catalogue Number: 1088
• Device Lot Number: 0022925827
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/06/2019
• Initial Date FDA Received: 07/02/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/12/2018
• 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