MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORP/ BSC UROLOGY/GYNECOLOGY URETERAL STENT

Model Number M0061921330

Device Problems Break (1069); Detachment Of Device Component (1104)

Patient Problems Headache (1880); Pain (1994); Respiratory Distress (2045); Sore Throat (2396); Hematuria (2558)

Event Date 02/07/2018

Event Type  Injury  

Event Description

Calcified upper and lower ends of a ureteral stent.There was a broken upper end to the stent.Cystoscopy.Successful placement of a new right ureteral stent, but she does have a retained fragment of stent that is calcified at the upper end and will require removal post-delivery.She is (b)(6) pregnant.History of present illness: 18 years olf g1po at 28.5 weeks with h/o nephrolithiasis and stent placement presents with complaints of hematuria and flank pain.The patient is s/p cystoscopy, right retrograde pyelogram, removal of old right ureteral stent and placement of new right ureteral stent in (b)(6) 2017.She has done well since then; however, over the last few days, she has noticed blood in her urine and 10/10 right sided flank pain when she needs to urinate.She passed a small stone yesterday.She denies ctx, vb, lof, pree, uti sxs, +fm.She endorses a temperature of 101f this am along with a dry cough, ha, and sore throat.She has had these symptoms over the last 36 hours.She reports that her mother in law had an uri 1-2 weeks ago.

• Brand Name: URETERAL STENT
• Type of Device: URETERAL STENT
• Manufacturer (Section D): BOSTON SCIENTIFIC CORP/ BSC UROLOGY/GYNECOLOGY
• MDR Report Key: 7352140
• MDR Text Key: 102990958
• Report Number: MW5075940
• Device Sequence Number: 1
• Product Code: FAD
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 03/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M0061921330
• Device Lot Number: 20866196
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 18 YR