MAUDE Adverse Event Report: BOSTON SCIENTIFIC - SPENCER TRAPEZOID¿ RX; LITHOTRIPTOR, BILIARY MECHANICAL

Model Number M00510890

Device Problem Difficult to Open or Close (2921)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/28/2015

Event Type  malfunction  

Manufacturer Narrative

On (b)(4), it was communicated that the surgeon completed the surgery with another retractor.In addition, on (b)(4) it was reported that patient's muscles were strong, but not unusual.On (b)(4) 2015 the r&d project manager performed a preliminary investigation: looking at the photos, we can notice that breakage occurs on the curved part, internal surface that seems weakened.Batch review performed on (b)(4) 2015: lot 1551624: 28 items manufactured and released on 29 jul 2015.No anomalies found related to the problem.One similar event registered on this lot up to now (mdr 2015-00334).On (b)(4), the same person analyzed the retrieved instrument commenting as following: we can notice that breakage occurs on the curved part: the internal surface is weakened, and this means that, due to traction force applied, the different layers of the materials has been unstuck.It seems that the instrument has been used following the surgical technique but we cannot be certain about this.It should also be possible that the fatigue affects the material behaviour.

Event Description

It was reported to boston scientific corporation that a trapezoid¿ rx basket was used during a stone removal procedure performed on (b)(6) 2015.According to the complainant, during introduction, the physician noticed that the basket would not open.The procedure was completed with another trapezoid¿ rx basket.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 ¿stable." this event has been deemed a reportable event based on the investigation results; side car-rx (guidewire port) pushback.

• Brand Name: TRAPEZOID¿ RX
• Type of Device: LITHOTRIPTOR, BILIARY MECHANICAL
• Manufacturer (Section D): BOSTON SCIENTIFIC - SPENCER; 780 brookside drive; spencer IN 47460
• Manufacturer (Section G): BOSTON SCIENTIFIC - SPENCER; 780 brookside drive; spencer IN 47460
• Manufacturer Contact: nancy cutino ; 100 boston scientific way; marlborough, MA 01752 ; 5086834000
• MDR Report Key: 5312097
• MDR Text Key: 34608428
• Report Number: 3005099803-2015-03513
• Device Sequence Number: 1
• Product Code: LQC
• Combination Product (y/n): N
• Reporter Country Code: CN
• PMA/PMN Number: K040447
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/24/2015

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: Physician
• Device Expiration Date: 10/17/2015
• Device Model Number: M00510890
• Device Catalogue Number: 1089
• Device Lot Number: 17375814
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/20/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/24/2015
• Initial Date FDA Received: 12/18/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/20/2014
• 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