MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION PERCUFLEX PLUS; CATHETER, BILIARY, DIAGNOSTIC

Model Number	M0061752740
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/18/2019
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).A percuflex plus stent was returned for analysis.A visual evaluation of the returned device revealed that the shaft of the stent was detached.The returned section was found to be buckled/accordion.Moreover this section has a sensor guidewire stuck inside of the stent.The most distal section of the stent and the suture string was not returned for analysis.Based on the product analysis, the issue occured during the withdrawal/closure.It is important to mention that no issues were reported by the customer during the unpacking, preparation and during the introduction.Moreover, device has the working length buckled, however, this failure is known to be generated due to the force used when the stent is pushed up with the pusher/positioner over the guidewire or when the stent was removed; therefore, the encountered issues are most likely that it were generated due to the manipulation of the device or due to the interaction with other devices during the procedure.Therefore, "adverse event related to procedure" is selected as the most probable root cause for the complaint.A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly and performance specifications at the time of release for distribution.
Event or Problem Description
It was reported to boston scientific corporation that a percuflex plus stent was used during a ureteroscopy procedure in the ureter, performed on (b)(6) 2019.According to the complainant, during closure of the procedure, when the physician attempted to deploy the stent, there was difficulty retracting the guidewire and when the stent was pulled back, stent buckled/accordion was observed.The physician used a laser fiber inside the bladder to cut the guidewire and was able to remove the stent outside the patient.A different model of stent was opened and successfully completed the procedure.There was no serious injury, nor were there any adverse patient effects reported as a result of this event.The condition of the patient at the conclusion of the procedure was reported to be stable.Investigation results revealed the stent shaft was detached, therefore this event has been deemed an mdr reportable event.

• Brand Name: PERCUFLEX PLUS
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 9125063
• Report Number: 3005099803-2019-04731
• Device Sequence Number: 2402087
• Product Code: FAD
• UDI-Device Identifier: 08714729041214
• UDI-Public: 08714729041214
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• 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
• Report Date (Section B): 09/26/2019

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: M0061752740
• Device Catalogue Number: 175-274
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/13/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/04/2019
• Initial Report FDA Received Date: 09/26/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 71 YR