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 Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/24/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Initial reporter facility name: (b)(6) hospital.
Event or Problem Description
It was reported that tip detachment occurred.An imager ii diagnostic catheter was selected for use during a digital subtraction angiography procedure.Vascular access was gained via the right radial artery.Multiple guidewires are catheters were advanced through the aortic arch of the patient due to the specificity of the arch.After completion of angiography the imager ii was withdrawn.It was observed that the end of the catheter was fractured and the detached portion was left in the right brachial artery.The length of the detached piece was measured to be 3cm.The patient did not experience any abnormal feeling during movement and there was no discomfort, bruising or paleness to the patient.The fractured piece did not influence blood flow.The following day the physician elected to remove the fractured part under local anesthesia.The patient was stable and there were no reported complications.

• 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: 9482209
• Report Number: 2134265-2019-15873
• Device Sequence Number: 3542150
• Product Code: DQO
• UDI-Device Identifier: 08714729355168
• UDI-Public: 08714729355168
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 12/17/2019

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: 03/12/2021
• Device Model Number: 38270
• Device Catalogue Number: 38270
• Device Lot Number: 0000139512
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/11/2019
• Initial Report FDA Received Date: 12/17/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 52 YR