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

Model Number M0061453620

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/26/2018

Event Type  malfunction  

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 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.

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 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
• Type of Device: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 8178641
• MDR Text Key: 130918804
• Report Number: 3005099803-2018-62090
• Device Sequence Number: 1
• Product Code: FAD
• UDI-Device Identifier: 08714729040330
• UDI-Public: 08714729040330
• Combination Product (y/n): N
• PMA/PMN Number: K834468
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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 Manufacturer Received: 11/27/2018
• Initial Date FDA Received: 12/19/2018
• Supplement Dates Manufacturer Received: 01/10/2019
• Supplement Dates FDA Received: 01/31/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1