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

Device Problems Calcified (1077); Difficult to Remove (1528)

Patient Problem Perforation (2001)

Event Date 09/30/2016

Event Type  Injury  

Manufacturer Narrative

The complainant was unable to provide the suspect device upn and lot number; therefore, the lot expiration and device manufacture dates are unknown.(b)(6).(b)(4).The complainant indicated that the device will not be returned for evaluation; therefore, a failure analysis of the complaint device cannot be completed.If any further relevant information is received, a supplemental mdr will be filed.

Event Description

It was reported that a percuflex ureteral stent was implanted into the patient for the treatment of left ureteral stone during a percutaneous nephrolithotomy and flexible ureteroscopy procedure.On (b)(6) 2016, the patient presented with a left ureteral stone.On (b)(6) 2016 a percuflex plus ureteral stent was implanted.It was noted that the physician was "unable to remove all stones due to severe impaction/location" and the patient experienced a "small ureteral perforation".The cause of the perforation is unknown.The patient was sent to the post-anesthesia care unit in stable condition.The patient was discharged on (b)(6) 2016.On (b)(6) 2016, a procedure to remove the percuflex plus ureteral stent was performed.It was noticed that the stent was encrusted and was difficult to remove.The stent was able to be successfully removed, and no new device was implanted.The patient returned to the recovery room in good condition.

• Brand Name: PERCUFLEX PLUS SUREDRIVE
• Type of Device: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCENTIFIC CORPORATION; 2546 calle primera; alajuela ; CS
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 11426940
• MDR Text Key: 238610100
• Report Number: 3005099803-2021-00913
• Device Sequence Number: 1
• Product Code: FAD
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/05/2021

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
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/09/2021
• Initial Date FDA Received: 03/07/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 49 YR