MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION IMAGER II ANGIOGRAPHIC CATHETER; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Model Number 38270

Device Problem Detachment of Device or Device Component (2907)

Patient Problems No Consequences Or Impact To Patient (2199); Device Embedded In Tissue or Plaque (3165)

Event Date 12/01/2019

Event Type  Injury  

Manufacturer Narrative

Date of event: no date provided, used the first date in the month of the aware date.

Event Description

It was reported that the tip detached and remains in the patient.A imager ii angiographic catheter was selected for use.During the procedure, the tip of the device broke and remains in the lesion.The patient's status was stable.

Manufacturer Narrative

Date of event: no date provided, used the first date in the month of the aware date.

Event Description

It was reported that the tip detached and remains in the patient.A imager ii angiographic catheter was selected for use.During the procedure, the tip of the device broke and remains in the lesion.The patient's status was stable.It was further reported intervention occurred to remove the device component and the patient was stable after intervention.

• Brand Name: IMAGER II ANGIOGRAPHIC CATHETER
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 9503426
• MDR Text Key: 173337847
• Report Number: 2134265-2019-15996
• Device Sequence Number: 1
• Product Code: DQO
• UDI-Device Identifier: 08714729354963
• UDI-Public: 08714729354963
• Combination Product (y/n): N
• PMA/PMN Number: K121694
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 01/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/10/2020
• Device Model Number: 38270
• Device Catalogue Number: 38270
• Device Lot Number: 0000133737
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/13/2019
• Initial Date FDA Received: 12/20/2019
• Supplement Dates Manufacturer Received: 12/24/2019
• Supplement Dates FDA Received: 01/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention