MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION COMET II; TRANSDUCER, PRESSURE, CATHETER TIP

Model Number 2404-01

Device Problem Unsealed Device Packaging (1444)

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

Event Date 01/09/2023

Event Type  malfunction  

Manufacturer Narrative

A photograph provided to boston scientific (bsc) showed that there were three shelf boxes damaged at the corners.The shelf boxes were torn and crushed.The appearance of the damage is consistent to damage that can be caused during storage or transportation.As a result, the event most likely happened due to transportation or storage of the device before it arrived at the facility.Manufacturing has strict quality practices in place to safeguard against any devices that do not meet bsc strict quality process and controls in place.Per the device history review that was completed, the device passed all quality checks before shipment.There was no indication of a manufacturing issue.

Event Description

It was reported that the inner sterile package of the product was compromised.A comet ii pressure guidewire was unpacked upon receipt at the hospital.Upon opening the shipping box, it was noted that the sterile packaging appeared to have a hole in it.This product was not used and there was no patient involved in relation to this event.

• Brand Name: COMET II
• Type of Device: TRANSDUCER, PRESSURE, CATHETER TIP
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer Contact: jay johnson ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 16280217
• MDR Text Key: 308591243
• Report Number: 2124215-2023-03428
• Device Sequence Number: 1
• Product Code: DXO
• UDI-Device Identifier: 08714729960140
• UDI-Public: 08714729960140
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2404-01
• Device Catalogue Number: 2404-01
• Device Lot Number: 0030268719
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/09/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/03/2022
• 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