MAUDE Adverse Event Report: BOSTON SCIENTIFIC - COSTA RICA (COYOL) URETERAL DILATION SET; DILATOR, CATHETER, URETERAL

Model Number UNK268

Device Problem Detachment Of Device Component (1104)

Patient Problems Pain (1994); Urinary Tract Infection (2120)

Event Date 09/02/2012

Event Type  Injury  

Event Description

Note: this report is one of two complaints that pertain to the same event (manufacturer report # 3005099803-2014-03921 and manufacturer report # 3005099803-2014-03922).It was reported to boston scientific corporation that a drainage stent and ureteral dilation set were implanted during a procedure performed on (b)(6) 2009.According to the complainant, post procedure, the patient suffered from pain, recurrent urinary tract infections, cysts and other medical conditions for about two years.During this time, the patient was consistently seen and treated by the physician.However, the cause of patient¿s conditions remained undiscovered.On (b)(6) 2011, a ct scan of the patient¿s abdomen and pelvis showed a broken stent which coiled in the in the collecting system of the right kidney and in the upper right ureter.On (b)(6) 2011, cystoscopy, right retrograde pyelogram, right ureteral stent insertion, and right extracorporeal shockwave lithotripsy was performed and confirmed that the fragmented stent in the kidney was from the previously implanted stent.Additionally, on (b)(6) 2012, a pathology report showed a monofilament suture was retained in patient¿s body.According to the complainant, as a result of this event, the patient suffered irreversible damage to organs, including but not limited to kidney which causes great amount of pain.Additionally, the patient has required years of medical treatment.

Manufacturer Narrative

The complainant was unable to report the upn and lot number; therefore, the manufacture date and expiration date are unknown.Reported event of suture detached.The complainant indicated that the device will not be returned for evaluation; therefore, a failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental mdr will be filed.

• Brand Name: URETERAL DILATION SET
• Type of Device: DILATOR, CATHETER, 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: 4324446
• MDR Text Key: 16557713
• Report Number: 3005099803-2014-03922
• Device Sequence Number: 1
• Product Code: EZN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K851144
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Company Representative
• Reporter Occupation: Attorney
• Type of Report: Initial
• Report Date: 11/14/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/12/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UNK268
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/14/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention