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

Model Number	M006175262110
Medical Device Problem Codes	Bent (1059); Difficult to Remove (1528)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.It was reported the device was not used past its expiry.(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 removed during a stent replacement procedure performed in the ureter.The date of the procedure was not reported.According to the complainant, there was difficulty in removing the stent.During procedure, it was noticed that the renal side tail of the stent would not become straight when the guidewire was inserted into it.The guidewire came out from the side hole of the stent tail.The stent was removed successfully with the guidewire after several attempts.A new stent was then implanted.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
(b)(4).Investigation results: a visual analysis of the returned stent found no anomalies or damages to the device.A functional inspection was performed, a mandrel 0.038 inches was inserted and advanced through the catheter, it passed through properly without resistance and both pigtails were straightened properly as expected while the mandrel remained inserted consequently not confirming the event of the pigtail unable to be straightened.The product could not be functionally evaluated with respect to the procedural factors encountered during the procedure therefore the failure reported as ¿stent difficulty removing¿ also could not be confirmed.The device showed no evidence of either the alleged issue or any defect which could have contributed to the event.Therefore", not confirmed returned" is selected as the most probable root cause for this complaint.
Event or Problem Description
It was reported to boston scientific corporation that a percuflex¿ plus stent was removed during a stent replacement procedure.According to the complainant, there was difficulty in removing the stent.During procedure, it was noticed that the renal side tail of the stent would not become straight even when the guidewire was inserted into it.There were no patient complications reported as a result of this event.

• 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: 7349546
• Report Number: 3005099803-2018-00809
• Device Sequence Number: 10772528
• Product Code: FGE
• UDI-Device Identifier: 08714729297413
• UDI-Public: 08714729297413
• Combination Product (Y/N): N
• 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): 02/21/2018

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 Model Number: M006175262110
• Device Catalogue Number: 175-262-11
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/26/2018
• Initial Date Received by Manufacturer: 02/21/2018
• Supplement Date Received by Manufacturer: 03/21/2018
• Initial Report FDA Received Date: 03/19/2018
• Supplement Report FDA Received Date: 04/16/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1