MAUDE Adverse Event Report: BOSTON SCIENTIFIC - COSTA RICA (COYOL) PERCUFLEX¿ PLUS; CATHETER, BILIARY, DIAGNOSTIC

Model Number	M006175254050
Medical Device Problem Codes	Calcified (1077); Difficult to Remove (1528)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The complainant was unable to report the lot number; therefore, the manufacture date and the expiration date are unknown.However, the complainant reported that the device was not expired.Initial reporter phone number: (b)(6).(b)(4).According to the complainant, the suspect device has been disposed and is not available for return.If any further relevant information is received, a supplemental mdr will be filed.
Event or Problem Description
It was reported to boston scientific corporation that a percuflex¿ plus stent was used in the ureter and kidney during a ureteroscopy and double j placement procedure on an unknown date.According to the complainant, post procedure, it was noted that the stent was calcified in the tail of the double j stent.It was also reported that the stent was stuck in the renal j pelvis.There were no patient complications reported as a result of this event.Attempts to gain further information regarding the event have been unsuccessful to date, should any relevant information be provided, a supplemental mdr will be filed.
Event or Problem Description
It was reported to boston scientific corporation that a percuflex plus stent was used in the ureter and kidney, during a ureteroscopy and double j placement procedure performed on an unknown date.According to the complainant, post procedure, it was noticed that the stent was calcified in the tail of the double j stent.It was also reported that the stent was stuck in the renal j pelvis.The patient was sent to surgery for removal of the stuck stent.There were no patient complications reported as a result of this event.Attempts to gain further information regarding the event have been unsuccessful to date, should any relevant information be provided, a supplemental mdr will be filed.

• Brand Name: PERCUFLEX¿ PLUS
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC - COSTA RICA (COYOL); 2546 first street; propark free zone; alajuela ; CS
• MDR Report Key: 7033784
• Report Number: 3005099803-2017-03441
• Device Sequence Number: 13895613
• Product Code: FGE
• UDI-Device Identifier: 08714729170082
• UDI-Public: 08714729170082
• Combination Product (Y/N): N
• Initial Reporter Country: JO
• PMA/510(K) Number: K924608
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/25/2017

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 Model Number: M006175254050
• Device Catalogue Number: 175-254-05
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/25/2017
• Supplement Date Received by Manufacturer: 12/22/2017
• Initial Report FDA Received Date: 11/15/2017
• Supplement Report FDA Received Date: 01/09/2018
• 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