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 Consequences Or Impact To Patient (2199)
Date of Event	02/03/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device component code relates to device problem code for the reported event of stent calcified.Device component code relates to device problem code for the reported event of stent difficulty removing.A visual analysis of the returned device found that it had residues of calcification and no other anomalies or damages were noted.Based on product analysis, the encountered defect (stent calcified) may cause difficulties during the withdrawal of the device.Therefore, based on all available information the most probable cause for this complaint is considered ¿anticipated procedural complication¿ since the complaint is due to a known physiological effects of the procedure noted within the directions for use.A review of the device history record (dhr) was performed and no deviation was found.A labeling review was performed and it was found out that there is no evidence that the device was used in a manner inconsistent with the labeling.A search of the complaint database revealed that no similar complaints exist for the specified lot.
Event or Problem Description
It was reported to boston scientific corporation that a percuflex¿ plus stent was previously implanted in the ureter and kidney on (b)(6) 2017.It was removed during a ureteroscopy and double j placement procedure performed on (b)(6) 2018.According to the complainant, during removal, it was noticed that the stent was encrusted.It was reported that difficulty in removing the stent was encountered, and it took more than two hours to remove.A cystolitholapaxy was done to break up the encrustation and the entire stent was removed with the use of forceps.There were no patient complications reported as a result of this event, and the patients¿ condition at the conclusion of the procedure was reported to be ¿stable¿.
Additional Manufacturer Narrative
Additional information for stent implant and explant dates reported.
Event or Problem Description
It was reported to boston scientific corporation that a percuflex¿ plus stent was previously implanted in the ureter and kidney on (b)(6) 2017.It was removed during a ureteroscopy and double j placement procedure performed on (b)(6) 2018.According to the complainant, during removal, it was noticed that the stent was encrusted.It was reported that difficulty in removing the stent was encountered, and it took more than two hours to remove.A cystolitholapaxy was done to break up the encrustation and the entire stent was removed with the use of forceps.There were no patient complications reported as a result of this event, and the patients¿ condition at the conclusion of the procedure was reported to be ¿stable¿.**additional information received on 07mar2018** stent was implanted on (b)(6) 2017 and was explanted on (b)(6) 2017.

• 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: 7307967
• Report Number: 3005099803-2018-00537
• Device Sequence Number: 19099406
• Product Code: FGE
• UDI-Device Identifier: 08714729170082
• UDI-Public: 08714729170082
• Combination Product (Y/N): N
• PMA/510(K) Number: K924608
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/06/2018

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: 11/30/2019
• Device Model Number: M006175254050
• Device Catalogue Number: 175-254-05
• Device Lot Number: 0020439676
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/14/2018
• Initial Date Received by Manufacturer: 02/06/2018
• Supplement Date Received by Manufacturer: 03/07/2018
• Initial Report FDA Received Date: 03/01/2018
• Supplement Report FDA Received Date: 03/20/2018
• 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