MAUDE Adverse Event Report: BOSTON SCIENTIFIC - COSTA RICA (COYOL) POLARIS? ULTRA; STENT, URETERAL

Model Number M006192122090

Device Problem Torn Material (3024)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/06/2014

Event Type  malfunction  

Event Description

It was reported to boston scientific corporation that a polaris¿ ultra stent set was used during an extracorporeal shock-wave lithotripsy procedure performed on (b)(6) 2014.According to the complainant, during the procedure, the polaris¿ ultra stent had difficulty advancing into the urethra and the device bent.Four more attempts were done with no success.The procedure was completed with a different device.The patient¿s ureteral orifice had a little redness due to numbers of placement attempts.The patient's condition at the conclusion of the procedure was reported to be stable.This event has been deemed a reportable event based on the investigation results; stent ripped/torn.

Manufacturer Narrative

(b)(4).Investigation results: stent torn.A visual analysis on the returned polaris ultra stent set was performed.The stent has a renal pigtail torn, the tip was split/ripped and the bladder pigtail was accordioned.The sensor guidewire corewire was stretched.All the outer diameter measurements of the guidewire are within specification.Functional evaluation was performed.A mandrel 0.038 inches was inserted through the stent and it passed properly without resistance.Additionally, the returned sensor guidewire was inserted through the stent and still it passed properly without resistance.The issue was noted inside the patient during the procedure, moreover, there were some attempts to pass the device through the ureter.Most likely, the damages noted on the device could have been related from anatomical and procedural factors.Therefore, the most probable root cause for this complaint is operational context.The device history record review found the device met all manufacturing specifications.

• Brand Name: POLARIS? ULTRA
• Type of Device: STENT, URETERAL
• Manufacturer (Section D): BOSTON SCIENTIFIC - COSTA RICA (COYOL); 2546 first street; propark free zone; alajuela ; CS
• Manufacturer (Section G): BOSTON SCIENTIFIC - COSTA RICA (COYOL); 2546 first street; propark free zone; alajuela ; CS
• Manufacturer Contact: nancy cutino ; 100 boston scientific way; marlborough, MA 01752 ; 5086834000
• MDR Report Key: 4306031
• MDR Text Key: 5085364
• Report Number: 3005099803-2014-03885
• Device Sequence Number: 1
• Product Code: FAD
• Combination Product (y/n): N
• Reporter Country Code: MX
• 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
• Report Date: 11/10/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2014
• Device Model Number: M006192122090
• Device Catalogue Number: 192-122-09
• Device Lot Number: 15172494
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/25/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/10/2014
• Initial Date FDA Received: 12/08/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/13/2012
• 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 Age: 44 YR
• Patient Weight: 90