MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION TRAPEZOID RX; LITHOTRIPTOR, BILIARY MECHANICAL

Model Number M00510870

Device Problems Obstruction of Flow (2423); Material Deformation (2976); Material Split, Cut or Torn (4008)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/21/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The returned trapezoid rx was analyzed, and a visual evaluation noted that the side car rx tunnel was torn and pushed back 5mm which is out of specification.Additionally, the working length was not kinked, but the sheath was torn.The basket was retracted and the tip was still attached to the basket when it was received.A functional evaluation noted that the basket was able to open and close without any issues.A second functional inspection was performed by filling the syringe with water and injecting it through the device.The water ran through the entire device and came out from the needle tip indicating that the device was not blocked/occluded.Thus, the reported complaint was not confirmed.Based on all available information, the most probable root cause for the failures found (sheath torn, side car torn, and side car push back) is adverse event related to procedure since the event occurred during the procedure and the device had no influence on the event.A review of the device history record (dhr) confirmed that the device met all material, assembly, and product specifications at the time of release to distribution.

Event Description

It was reported to boston scientific corporation that a trapezoid rx lithotripter basket was used in the common bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2020.According to the complainant, during the procedure, the tech experienced difficulty delivering the contrast.Attempts were made with the basket opened and closed, however these were unsuccessful.The device was removed from the patient and tried again.It was noticed that the contrast was flowing out of an area on the catheter instead of the tip of the catheter.The procedure was completed with this device.There were no patient complications reported as a result of this event.The investigation results revealed the side car rx tunnel was pushed back 5mm which is out of specification.Therefore, this is now an mdr reportable event.

• Brand Name: TRAPEZOID RX
• Type of Device: LITHOTRIPTOR, BILIARY MECHANICAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 780 brookside drive; spencer IN 47460
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 10743601
• MDR Text Key: 225869865
• Report Number: 3005099803-2020-04908
• Device Sequence Number: 1
• Product Code: LQC
• UDI-Device Identifier: 08714729296386
• UDI-Public: 08714729296386
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K040447
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/27/2020

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: 05/26/2021
• Device Model Number: M00510870
• Device Catalogue Number: 1087
• Device Lot Number: 0025536790
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/11/2020
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/01/2020
• Initial Date FDA Received: 10/27/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/26/2020
• 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