MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ACCUSTICK II WITH 038 J-TIP WIRE; ACCESSORIES, CATHETER

Model Number 21GA X 15 CM

Device Problems Break (1069); Detachment of Device or Device Component (2907)

Patient Problem Foreign Body In Patient (2687)

Event Date 02/22/2019

Event Type  Injury  

Event Description

During a left pcn placement procedure the 0.018 wire included in the boston scientific accustick ii broke off inside the patient.The wire was retrieved using a snare and no additional monitoring was needed.

• Brand Name: ACCUSTICK II WITH 038 J-TIP WIRE
• Type of Device: ACCESSORIES, CATHETER
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752 1234
• MDR Report Key: 8409742
• MDR Text Key: 138546525
• Report Number: MW5084800
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 02/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/11/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/13/2021
• Device Model Number: 21GA X 15 CM
• Device Catalogue Number: M001207020
• Device Lot Number: 22113502
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• 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 Outcome(s): Required Intervention
• Patient Age: 94 YR