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

Model Number M0061602100

Device Problems Break (1069); Difficult to Remove (1528)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/01/2016

Event Type  Injury  

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 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2016, a cystectomy procedure was performed and two diversion stents were implanted, one in each ureter.The stents were withdrawn during a scheduled stent removal on (b)(6) 2016.The stent in the left ureter was removed without any problems.However, the stent at the right ureter ¿snapped¿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.

Manufacturer Narrative

The second physician was dr.(b)(6).

Event 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2016, a cystectomy procedure was performed and two diversion stents were implanted, one in each ureter.The stents were withdrawn during a scheduled stent removal on (b)(6) 2016.The stent in the left ureter was removed without any problems.However, the stent at the right ureter ¿snapped¿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
• Type of Device: CATHETER, NEPHROSTOMY
• 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: 6184795
• MDR Text Key: 62670839
• Report Number: 3005099803-2016-03907
• Device Sequence Number: 1
• Product Code: LJE
• UDI-Device Identifier: 08714729297178
• UDI-Public: (01)08714729297178(17)20170416(10)0016013926
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K830803
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/02/2016
• Initial Date FDA Received: 12/19/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/10/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/29/2013
• 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: 75 YR