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

Model Number	M006175254050
Medical Device Problem Code	Calcified (1077)
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 provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.Device component code relates to device problem code for the reported event of stent calcified.The device has not been received for analysis.Upon receipt and 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 double j stent.It was also reported that the stent was stuck in the renal j pelvis.The patient was sent to surgery for stent removal.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 percuflexplus 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 double j stent.It was also reported that the stent was stuck in the renal j pelvis.The patient was sent to surgery for stent removal.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: 7278873
• Report Number: 3005099803-2018-00446
• Device Sequence Number: 2378466
• 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): 01/29/2018

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: 06/30/2020
• Device Model Number: M006175254050
• Device Catalogue Number: 175-254-05
• Device Lot Number: 0021180607
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/29/2018
• Supplement Date Received by Manufacturer: 01/29/2018
• Initial Report FDA Received Date: 02/16/2018
• Supplement Report FDA Received Date: 02/26/2018
• 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