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

Model Number M0063901050

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

Patient Problem Perforation (2001)

Event Date 06/02/2020

Event Type  Injury  

Manufacturer Narrative

The complainant was unable to provide the suspect device lot number: therefore, the lot expiration and device manufacture dates are unknown.Initial reporter: this event was reported by post market clinical research specialist ii, the initial reporter facility name is: (b)(6).(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 segura basket was used during a cysureth-uretr&/pyelscpy; remv calc (cystourethroscopy, with ureteroscopy and/or pyeloscopy; with removal or manipulation of calculus (ureteral catheterization is included) procedure performed on (b)(6) 2020.During procedure, ureteral perforation occurred.Rstent flex stre vl 6frx22-30cc edi is a possible treatment.

Manufacturer Narrative

Block d4: upn number has been corrected.Block d4, h4: the complainant was unable to provide the suspect device lot number: therefore, the lot expiration and device manufacture dates are unknown.Block e: this event was reported by post market clinical research specialist ii, the initial reporter facility name is: premier healthcare urban, northeast, middle atlantic block h6: the patient code e2114 captures the reportable event of perforation.

Event Description

It was reported to boston scientific corporation, through a post market clinical follow up (pmcf) of retrospective data collection, that a segura basket was used during a cysureth-uretr&/pyelscpy; remv calc (cystourethroscopy, with ureteroscopy and/or pyeloscopy; with removal or manipulation of calculus (ureteral catheterization is included) procedure performed on (b)(6) 2020.During procedure, ureteral perforation occurred.Rstent flex stre vl 6frx22-30cc edi is a possible treatment.

• Brand Name: SEGURA HEMISPHERE
• 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; 80 brookside drive; spencer IN 47460
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 16252656
• MDR Text Key: 308240042
• Report Number: 3005099803-2023-00257
• Device Sequence Number: 1
• Product Code: FFL
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Health Professional,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 03/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/27/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: M0063901050
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/07/2023
• 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): Required Intervention
• Patient Age: 69 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White