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

Model Number	38270
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); Device Embedded In Tissue or Plaque (3165)
Date of Event	12/01/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event: no date provided, used the first date in the month of the aware date.
Event or Problem 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.
Additional Manufacturer Narrative
Date of event: no date provided, used the first date in the month of the aware date.
Event or Problem 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
• Common Device Name: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 9503426
• Report Number: 2134265-2019-15996
• Device Sequence Number: 13750411
• Product Code: DQO
• UDI-Device Identifier: 08714729354963
• UDI-Public: 08714729354963
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K121694
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: 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 Received by Manufacturer: 12/13/2019
• Supplement Date Received by Manufacturer: 12/24/2019
• Initial Report FDA Received Date: 12/20/2019
• Supplement Report FDA Received Date: 01/07/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention