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

Model Number	M006175253050
Medical Device Problem Code	Calcified (1077)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Although the suspect device has been received, the evaluation has not been completed.Therefore, the cause of the reported malfunction has not been determined.Upon completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental mdr will be filed.
Event or Problem Description
It was reported to boston scientific corporation that a percuflex¿ plus stent was to be removed from the ureter and kidney, during a ureteroscopy and double j placement procedure performed on an unknown date.According to the complainant, during procedure, it was noticed that the stent was calcified in the tail of the 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.
Additional Manufacturer Narrative
A visual evaluation revealed that only the proximal section of the stent was returned.Analysis of the returned section found that it was cut and there were residues of calcification on it.Based on the product analysis, this is considered an adverse event associated with retrograde positioned indwelling ureteral stents including but not limited to encrustation; stone formation.The complaint is a known physiological effect of the procedure noted within the directions for use.It is possible that the way in which the device was removed may have contributed to the condition of the unit returned (catheter cut), this could have been performed by the customer with an unknown instrument, since the section of the device found cut shows that the surface has no irregularities and is smooth, which is evidence that it was not caused due to excess of force applied to the device.Therefore the most probable root cause for this event is "anticipated procedural complication".A review of the device history record (dhr) was performed and no deviation was found.
Event or Problem Description
It was reported to boston scientific corporation that a percuflex plus stent was to be removed from the ureter and kidney, during a ureteroscopy and double j placement procedure performed on an unknown date.According to the complainant, during procedure, it was noticed that the stent was calcified in the tail of the 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: 7278454
• Report Number: 3005099803-2018-00445
• Device Sequence Number: 19411679
• Product Code: FGE
• UDI-Device Identifier: 08714729339977
• UDI-Public: 08714729339977
• 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): 01/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2020
• Device Model Number: M006175253050
• Device Catalogue Number: 175-253-05
• Device Lot Number: 0021095242
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/01/2018
• Initial Date Received by Manufacturer: 01/28/2018
• Supplement Date Received by Manufacturer: 02/19/2018
• Initial Report FDA Received Date: 02/16/2018
• Supplement Report FDA Received Date: 03/08/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1