MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ACCUSTICK INTRODUCER SYSTEM; ACCESSORIES, CATHETER

Model Number M001207020

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 04/28/2019

Event Type  malfunction  

Event Description

The accustick system was being utilized by the ir physician for a percutaneous nephrostomy tube placement.As the system was being removed from the pt, it was noted by the physician that a small marking ring at the distal end of the system had detached and was still in the pt.The physician was able to carefully remove the ring.This marking ring is not supposed to detach from the system.The physician made a note that had he not noticed or not been able to retrieve the marking ring it would have had to have remained in the pt permanently.Devices will be returned only if mfrs provide prepaid shipping, packaging as per dot, or pick the item up.The details in the report are the extent to which we identify medications involved or pt contact.

• Brand Name: ACCUSTICK INTRODUCER SYSTEM
• Type of Device: ACCESSORIES, CATHETER
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION
• MDR Report Key: 8582767
• MDR Text Key: 144413650
• Report Number: MW5086398
• Device Sequence Number: 1
• Product Code: KGZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 04/29/2019

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 Model Number: M001207020
• Device Lot Number: 23443194
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/03/2019
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 32 MO