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

Model Number M00510880

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

Patient Problem No Patient Involvement (2645)

Event Date 03/14/2018

Event Type  malfunction  

Manufacturer Narrative

Visual analysis found the device returned with its original sealed package.The plastic tray was found deformed and slightly torn on the same location compromising the sterility of the device.Based on the information available, it is possible that the way in which the device was handled and manipulated during its process of storage or shipping may have contributed to the failure noted.It is most likely that a compressing force, probably something heavy was placed over the plastic tray, caused the damage to the tray and also led to tearing which compromised the sterility of the device.During its manufacturing process the product is inspected in regards to its integrity, however there is no control in how the units are handled at the field.It is concluded that the way in which the unit was handled and manipulated during unpacking may have contributed to the failure noted, therefore the most probable cause of this complaint will be documented as ¿handling damage".The device history record (dhr) review found that the device met all manufacturing specifications.A search of the complaint database revealed that no similar complaints exist for the specified lot.

Event Description

It was reported to boston scientific corporation that a trapezoid rx basket was unpacked on (b)(6) 2018.According to the complainant, during unpacking in the endoscopy suite, the device tray was found damage.The sterile barrier was not compromised.The procedure was completed with another trapezoid basket.There were no reported patient complications as a result of this event.This event has been deemed reportable based on the investigation results; package seal compromised.

• 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: 7533624
• MDR Text Key: 108899395
• Report Number: 3005099803-2018-01644
• Device Sequence Number: 1
• Product Code: LQC
• UDI-Device Identifier: 08714729296393
• UDI-Public: 08714729296393
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: K040447
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 04/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/22/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/12/2019
• Device Model Number: M00510880
• Device Catalogue Number: 1088
• Device Lot Number: 21732007
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/27/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/25/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/12/2018
• 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