MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION INTERLOCK; DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION

Model Number M001363610

Device Problem Activation Failure (3270)

Patient Problem Insufficient Information (4580)

Event Date 10/04/2021

Event Type  malfunction  

Event Description

We had 4 interlocks fail on one case for the same issue - they would not deploy.Ref (b)(4).Four different lot numbers: 23982116, 2783344, 23763218, 26584510.A fifth one was opened and used successfully.All 4 failures had patient contact but no patient harm.

• Brand Name: INTERLOCK
• Type of Device: DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 12744739
• MDR Text Key: 279822682
• Report Number: 12744739
• Device Sequence Number: 1
• Product Code: KRD
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/03/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M001363610
• Device Catalogue Number: M001363610
• Device Lot Number: 23982116, 2783344, 23763218,
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/08/2021
• Event Location: Hospital
• Date Report to Manufacturer: 11/03/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 25915 DA