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

Model Number	M0061453620
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/26/2018
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.(b)(4) captures the reportable event of stent broken.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 stent was to be used for a ureteral stent placement procedure to be performed in the ureter on (b)(6) 2018.According to the complainant, prior to insertion, the stent broke in half.The procedure was completed with another percuflex stent.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be fine.
Additional Manufacturer Narrative
Lot number updated to 0022393097.Problem code 1069 captures the reportable event of stent broken.A visual analysis of the returned percuflex stent found that it was damaged at the proximal end; the bladder pigtail was detached.The suture string was not present and was not returned for analysis.No other anomalies were noted.Based on the product analysis and all the gathered information it was determined that the failure encountered (stent detached), is consistent with damage that is normally caused when the suture is being pulled incorrectly or with excess of force.Therefore, the most probable cause of this complaint is adverse event related to procedure since it is most likely that due to procedural factors encountered during the procedure the performance of the product was limited.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 stent was to be used for a ureteral stent placement procedure to be performed in the ureter on (b)(6) 2018.According to the complainant, prior to insertion, the stent broke in half.The procedure was completed with another percuflex stent.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be fine.

• Brand Name: PERCUFLEX
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 8178641
• Report Number: 3005099803-2018-62090
• Device Sequence Number: 13886860
• Product Code: FAD
• UDI-Device Identifier: 08714729040330
• UDI-Public: 08714729040330
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K834468
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/31/2019

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 Expiration Date: 07/17/2021
• Device Model Number: M0061453620
• Device Catalogue Number: 145-362
• Device Lot Number: 0022393097
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/17/2018
• Initial Date Received by Manufacturer: 11/27/2018
• Supplement Date Received by Manufacturer: 01/10/2019
• Initial Report FDA Received Date: 12/19/2018
• Supplement Report FDA Received Date: 01/31/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1