MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ESCAPE; DISLODGER, STONE, BASKET, URETERAL, METAL

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Nausea (1970); Pain (1994); Urinary Tract Infection (2120)

Event Date 12/16/2018

Event Type  Injury  

Manufacturer Narrative

Patient's race is hispanic.The complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.Patient code (b)(6) captures the reportable event of nausea.Patient code (b)(6) captures the reportable event of pain.Patient code (b)(6) captures the reportable event of urinary tract infection.(b)(4).

Event Description

It was reported to boston scientific corporation, through a post market clinical follow up (pmcf) of retrospective data collection, that a zero tip basket was used during a ureteroscopy procedure performed on (b)(6) 2018.The patient was readmitted for intractable pain, nausea and urinary tract infection.The patient had multiple emergency room visits.

• Brand Name: ESCAPE
• Type of Device: DISLODGER, STONE, BASKET, URETERAL, METAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 780 brookside drive; 780 brookside drive IN 47460
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 15649599
• MDR Text Key: 302167066
• Report Number: 3005099803-2022-06217
• Device Sequence Number: 1
• Product Code: FFL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/21/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/27/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 25 YR
• Patient Sex: Female