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

Model Number M00510890

Device Problem Tear, Rip or Hole in Device Packaging (2385)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/06/2022

Event Type  malfunction  

Manufacturer Narrative

The exact date of the event is unknown.The provided event date was chosen as a best estimate based on the date that the manufacturer became aware of the event.(b)(4).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 medwatch will be filed.

Event Description

It was reported to boston scientific corporation that a trapezoid basket sterile pouch was found torn.During unpacking of the shipping box, one of trapezoid basket sterile pouch was found to be torn.This event did not occur during a procedure, did not involve a patient, and occurred outside of an operating room.

Manufacturer Narrative

Block h2: additional information: b3 date of event has been updated based on additional information received.Block h6: device code a020504 captures the event tear in device packaging.Block h10: the returned trapezoid basket was analyzed, and a visual evaluation observed that the packaging has a cutting mark from side to side with a tear in the middle.The packaging also has other cutting marks possibly made with a sharp object.The packaging keeps factory seals.The customer provided 3 pictures related to the complaint.The pictures showed the packaging of the device with a tear on it, also, the cardboard box where the damaged device was located.The reported complaint is confirmed.Based on all available information, it is possible that the problem could have happened during transport, or while the device was in storage.Therefore, the most probable root cause is cause traced to transport/storage.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.

Event Description

It was reported to boston scientific corporation that an trapezoid basket sterile pouch was found torn on june 6, 2022.During unpacking of the shipping box, one of trapezoid basket sterile pouch was found to be torn.This event did not occur during a procedure, did not involve a patient, and occurred outside of an operating room.

• 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: 14836368
• MDR Text Key: 303245134
• Report Number: 3005099803-2022-03466
• Device Sequence Number: 1
• Product Code: LQC
• UDI-Device Identifier: 08714729296409
• UDI-Public: 08714729296409
• Combination Product (y/n): N
• Reporter Country Code: IS
• PMA/PMN Number: K040447
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/27/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 04/07/2023
• Device Model Number: M00510890
• Device Catalogue Number: 1089
• Device Lot Number: 0029187055
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/06/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/07/2022
• 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