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

Model Number M0061921230

Device Problem Migration (4003)

Patient Problem Pain (1994)

Event Date 06/19/2022

Event Type  Injury  

Event Description

It was reported to boston scientific corporation that a polaris ultra ureteral stent was used during a ureteroscopy procedure in the kidney, performed on (b)(6) 2022.Post procedure, on (b)(6) 2022, the patient went to the hospital with a complaint of pain.An x-ray was taken and it was noticed that the stent had migrated from the kidney down to the urinary bladder.On (b)(6) 2022, a follow up procedure was performed to remove the stent.The migrated stent was retrieved with the use of a pair of biopsy forceps.Another polaris ultra ureteral stent was opened and successfully completed the procedure.There was no information of medication or treatment given for pain.

Manufacturer Narrative

The complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.(b)(4).The device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.

Event Description

It was reported to boston scientific corporation that a polaris ultra ureteral stent was used during a ureteroscopy procedure in the kidney, performed on (b)(6) 2022.Post procedure, on (b)(6) 2022, the patient went to the hospital with a complaint of pain.An x-ray was taken and it was noticed that the stent had migrated from the kidney down to the urinary bladder.On (b)(6) 2022, a follow up procedure was performed to remove the stent.The migrated stent was retrieved with the use of a pair of biopsy forceps.Another polaris ultra ureteral stent was opened and successfully completed the procedure.There was no information of medication or treatment given for pain.

Manufacturer Narrative

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 h6: medical device problem code a010402 captures the reportable event of stent migration.Impact code f22 captures the reportable event of unexpected diagnostic intervention.Patient code c2330 captures the reportable event of pain.Block h10: the returned device was analyzed, and a visual evaluation noted that the device received was not a bsc ureteral stent.It is not a polaris ultra stent 5f, there is no white pigtail and it is a 4.8f.There is no legend along the stent.It has an additional mark after what we consider the bladder band mark.It is quite similar to the marflow ag stent of the competence.No other issues with the device were noted.The reported event was not confirmed.According to the product analysis, the returned device it is not considered a device manufactured by boston scientific, during the analysis was concluded that the device is not a polaris ultra stent 5f, there is no white pigtail and it is a 4.8f, there is no legend along the stent, it has an additional mark after what we consider the bladder band mark and it is quite similar to the marflow ag stent of the competence.Therefore, no problem detected is selected as the most probable root cause for the complaint.

Manufacturer Narrative

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 h6: medical device problem code a010402 captures the reportable event of stent migration.Impact code f22 captures the reportable event of unexpected diagnostic intervention.Patient code c2330 captures the reportable event of pain.Block h10: the device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.

Event Description

It was reported to boston scientific corporation that a polaris ultra ureteral stent was used during a ureteroscopy procedure in the kidney, performed on (b)(6) 2022.Post procedure, on (b)(6) 2022, the patient went to the hospital with a complaint of pain.An x-ray was taken and it was noticed that the stent had migrated from the kidney down to the urinary bladder.On (b)(6) 2022, a follow up procedure was performed to remove the stent.The migrated stent was retrieved with the use of a pair of biopsy forceps.Another polaris ultra ureteral stent was opened and successfully completed the procedure.There was no information of medication or treatment given for pain.

• 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 ; CS
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 15017363
• MDR Text Key: 295913524
• Report Number: 3005099803-2022-03679
• Device Sequence Number: 1
• Product Code: FAD
• UDI-Device Identifier: 08714729124320
• UDI-Public: 08714729124320
• Combination Product (y/n): N
• Reporter Country Code: SA
• 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,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 09/12/2022

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: M0061921230
• Device Catalogue Number: 192-123
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/19/2022
• Initial Date FDA Received: 07/14/2022
• Supplement Dates Manufacturer Received: 07/27/2022; 08/17/2022
• Supplement Dates FDA Received: 08/19/2022; 09/12/2022
• Was Device Evaluated by Manufacturer?: No
• 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: 60 YR
• Patient Sex: Male
• Patient Weight: 83 KG