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.(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: 7033760
• Report Number: 3005099803-2017-03440
• Device Sequence Number: 1901313
• 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