MAUDE Adverse Event Report: BOSTON SCIENTIFIC - COSTA RICA (COYOL) PERCUFLEX¿ URINARY DIVERSION STENT SET; CATHETER, NEPHROSTOMY

Model Number	M0061602100
Medical Device Problem Codes	Break (1069); Difficult to Remove (1528)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/01/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).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 medwatch will be filed.
Event or Problem Description
It was reported to boston scientific corporation that two percuflex¿ urinary diversion stents were implanted during a cystectomy procedure performed on (b)(6) 2016 and were removed during a stent removal procedure performed on (b)(6) 2016 and another on (b)(6) 2016.According to the complainant, on (b)(6) 2016, a cystectomy procedure was performed and two diversion stents were implanted, one in each ureter.The stents were withdrawn during a scheduled stent removal on (b)(6) 2016.The stent in the left ureter was removed without any problems.However, the stent at the right ureter ¿snapped¿ while being pulled out, leaving a detached piece left inside the patient.On (b)(6) 2016, an attempt to remove the detached piece was made, but was unsuccessful.On (b)(6) 2016, a bigger nephrostomy balloon was placed.On (b)(6) 2016, an antegrade and retrograde ureteroscopy procedure was performed and successfully retrieved the remaining part of the stent.Attempts to obtain additional information regarding the circumstances surrounding this event have been unsuccessful to date.Should additional relevant details become available, a supplemental report will be submitted.
Additional Manufacturer Narrative
The second physician was dr.(b)(6).
Event or Problem Description
It was reported to boston scientific corporation that two percuflex¿ urinary diversion stents were implanted during a cystectomy procedure performed on (b)(6) 2016 and were removed during a stent removal procedure performed on (b)(6) 2016 and another on (b)(6) 2016.According to the complainant, on (b)(6) 2016, a cystectomy procedure was performed and two diversion stents were implanted, one in each ureter.The stents were withdrawn during a scheduled stent removal on (b)(6) 2016.The stent in the left ureter was removed without any problems.However, the stent at the right ureter ¿snapped¿ while being pulled out, leaving a detached piece left inside the patient.On (b)(6) 2016, an attempt to remove the detached piece was made, but was unsuccessful.On (b)(6) 2016, a bigger nephrostomy balloon was placed.On (b)(6) 2016, an antegrade and retrograde ureteroscopy procedure was performed and successfully retrieved the remaining part of the stent.Attempts to obtain additional information regarding the circumstances surrounding this event have been unsuccessful to date.Should additional relevant details become available, a supplemental report will be submitted.Additional information as of january 24, 2017: on (b)(6), the right ureter stent broke.The detached portion of stent was left inside the patient, from anastomosis to kidney.On (b)(6), the second physician, radiologist dr.(b)(6), attempted to pull out the remaining stent.However, the stent broke in two additional places.The stent broke each time the radiologist pulled on it.On (b)(6), graspers, baskets and forceps were used to remove the remaining parts of the stent.The patient was reportedly stable.

• Brand Name: PERCUFLEX¿ URINARY DIVERSION STENT SET
• Common Device Name: CATHETER, NEPHROSTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC - COSTA RICA (COYOL); 2546 first street; propark free zone; alajuela ; CS
• MDR Report Key: 6184795
• Report Number: 3005099803-2016-03907
• Device Sequence Number: 10852326
• Product Code: LJE
• UDI-Device Identifier: 08714729297178
• UDI-Public: (01)08714729297178(17)20170416(10)0016013926
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K830803
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/02/2016

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
• Operator of Device: Health Professional
• Device Expiration Date: 04/16/2017
• Device Model Number: M0061602100
• Device Catalogue Number: 160-210
• Device Lot Number: 0016013926
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 12/02/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/19/2016
• Supplement Report FDA Received Date: 02/10/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 75 YR