MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION POLARIS ULTRA; STENT, URETERAL

Model Number 15914846

Device Problem Break (1069)

Patient Problems Unspecified Infection (1930); Sepsis (2067)

Event Date 10/29/2022

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported to boston scientific corporation that a percuflex plus ureteral stent was used during a pieloplasty procedure in the ureter performed on (b)(6) 2022.Prior to discharge, it was noted that the stent shaft was broken, and a part remained inside the patient.The broken stent was successfully retrieved using a pair of forceps.The procedure was successfully completed.The patient experienced infection as a result of this event.The patient's condition at the conclusion of the procedure was expected to fully recover.

Manufacturer Narrative

Block h6: medical device code a0401 captures the reportable event of stent shaft broken.Problem code e1906 captures the reportable event of infection.Problem code e0306 captures the reportable event of sepsis.Problem code f08 captures the reportable event of hospitalization.Problem code f19 captures the reportable event of surgical intervention.Problem code f12 captures the reportable event of serious injury.Block h10: block b5 has been updated based on additional information received on december 16, 2022.Block d4 has been updated based on additional information received on january 10 providing the correct upn lot number.Block h11: blocks b5, a2, a3, and a4 have been corrected.

Event Description

It was reported to boston scientific corporation that a percuflex plus ureteral stent was used during a pyeloplasty procedure in the ureter performed on (b)(6) 2022.On (b)(6) 2022, the percuflex plus ureteral stent was removed without complication.On (b)(6) 2022, the patient was admitted for sepsis of urinary origin that required icu management, ct scan of the abdomen and showed a broken right catheter, leaving a part inside the kidney generating severe infection requiring a kidney bypass surgery with an emergency nephrectomy and stay in icu.The patient's condition at the conclusion of the procedure was expected to fully recover.

Manufacturer Narrative

Block h6: medical device code a0401 captures the reportable event of stent shaft broken.Block h10: block b5 has been updated based on additional information received december 16, 2022.

Event Description

It was reported to boston scientific corporation that a percuflex plus ureteral stent was used during a pieloplasty procedure in the ureter performed on (b)(6) 2022.Prior to discharge, it was noted that the stent shaft was broken, and a part remained inside the patient.The broken stent was successfully retrieved using a pair of forceps.The procedure was successfully completed.The patient experienced infection as a result of this event.The patient's condition at the conclusion of the procedure was expected to fully recover.

Event Description

It was reported to boston scientific corporation that a polaris ultra ureteral stent was used during a pyeloplasty procedure in the ureter performed on (b)(6) 2022.On (b)(6) 2022, the stent was removed without complication.On (b)(6) 2022, the patient was admitted for sepsis of urinary origin that required icu management, ct scan of the abdomen and showed a broken right catheter, leaving a part inside the kidney generating severe infection requiring a kidney bypass surgery with an emergency nephrectomy and stay in icu.The patient's condition at the conclusion of the procedure was expected to fully recover.Additional information received, on march 28, 2023, reported that the stent was successfully removed using foreign body forceps on october 26, 2022.It was also clarified the (computed tomography) ct scan that identified the broken stent was reportedly performed on october 29, 2022.The patient's outcome status was listed as in treatment.

Manufacturer Narrative

Corrected fields: block b3 date of event has been corrected.Block d6b explant date has been corrected.Block h6: imdrf device code a0401 captures the reportable event of stent shaft broken.Problem code e1906 captures the reportable event of infection.Problem code e0306 captures the reportable event of sepsis.Problem code f08 captures the reportable event of hospitalization.Problem code f19 captures the reportable event of surgical intervention.Problem code f12 captures the reportable event of serious injury.

Event Description

It was reported to boston scientific corporation that a polaris ultra ureteral stent was used during a pieloplasty procedure in the ureter performed on (b)(6) 2022.On (b)(6) 2022, the stent was removed without complication.On (b)(6) 2022, the patient was admitted for sepsis of urinary origin that required icu management, ct scan of the abdomen and showed a broken right catheter, leaving a part inside the kidney generating severe infection requiring a kidney bypass surgery with an emergency nephrectomy and stay in icu.The patient's condition at the conclusion of the procedure was expected to fully recover.Additional information received, on march 28, 2023, reported that the stent was successfully removed using foreign body forceps on (b)(6) 2022.It was also clarified the (computed tomography) ct scan that identified the broken stent was reportedly performed on (b)(6) 2022.The patient's outcome status was listed as in treatment.

Manufacturer Narrative

Additional information: block b5 has been updated based on additional information received on march 28, 2023.Block h6: medical device code a0401 captures the reportable event of stent shaft broken.Problem code e1906 captures the reportable event of infection.Problem code e0306 captures the reportable event of sepsis.Problem code f08 captures the reportable event of hospitalization.Problem code f19 captures the reportable event of surgical intervention.Problem code f12 captures the reportable event of serious injury.

• Brand Name: POLARIS ULTRA
• Type of Device: STENT, URETERAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 2546 calle primera; alajuela IN ; CS
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 15978404
• MDR Text Key: 308028792
• Report Number: 3005099803-2022-07257
• Device Sequence Number: 1
• Product Code: FAD
• UDI-Device Identifier: 08714729124429
• UDI-Public: 08714729124429
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: K010002
• 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,Followup,Followup,Followup,Followup
• Report Date: 06/12/2023

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 Model Number: 15914846
• Device Catalogue Number: 192-132
• Device Lot Number: 0029272732
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/21/2022
• Initial Date FDA Received: 12/14/2022
• Supplement Dates Manufacturer Received: 12/16/2022; 01/10/2023; 03/28/2023; 05/22/2023
• Supplement Dates FDA Received: 01/10/2023; 02/03/2023; 04/17/2023; 06/12/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/23/2022
• 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): Hospitalization; Required Intervention
• Patient Age: 47 YR
• Patient Sex: Male