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	Foreign Body In Patient (2687)
Date of Event	06/05/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Media analysis: the device was not returned for analysis; however, media from the clinical procedure was provided to boston scientific and reviewed.The media review concluded: the tip appeared to be broken and lodged in the upper chest area of the patient.Additional photos showed packaged devices.
Event or Problem Description
It was reported that the tip detached and was left inside the patient.On (b)(6) 2024, the patient was admitted to the hospital due to dizziness and cerebral vascular stenosis.On (b)(6) 2024, an imager ii angiographic catheter was selected for use in total cerebral angiography, which was performed under local anesthesia.A 0.035, 150cm zipwire guidewire was used to deliver the catheter to the aortic arch.The physician started rotating the imager ii catheter to get it into the left common carotid artery.After a few attempts, it was noted that the catheter's tip was abnormal, and the tip detached and began moving toward the descending aorta.The catheter was immediately removed, and outside the patient it was observed that the tip had fractured.Upon immediate examination, it was determined that the tip was located in the left renal artery branch.The patient was asymptomatic.The fragment was approximately 1cm and remained in the patient's left kidney.No attempts to remove the fragment were made.The procedure was not completed due to this event.The patient was in stable condition and was discharged on (b)(6) 2024.
Additional Manufacturer Narrative
Device eval by manufacturer: the imager ii diagnostic catheter was returned to boston scientific for analysis.Visual and microscopic inspection of the device revealed a detached tip located at 99.5 cm from the hub.Media was returned in the form of photos.The photos showed the packaging and diagnostic imaging of the tip detachment within the patient.Media review in conjunction with lab analysis was able to confirm the alleged tip detachment.
Event or Problem Description
It was reported that the tip detached and was left inside the patient.On (b)(6) 2024, the patient was admitted to the hospital due to dizziness and cerebral vascular stenosis.On (b)(6) 2024, an imager ii angiographic catheter was selected for use in total cerebral angiography, which was performed under local anesthesia.A 0.035, 150cm zipwire guidewire was used to deliver the catheter to the aortic arch.The physician started rotating the imager ii catheter to get it into the left common carotid artery.After a few attempts, it was noted that the catheter's tip was abnormal, and the tip detached and began moving toward the descending aorta.The catheter was immediately removed, and outside the patient it was observed that the tip had fractured.Upon immediate examination, it was determined that the tip was located in the left renal artery branch.The patient was asymptomatic.The fragment was approximately 1cm and remained in the patient's left kidney.No attempts to remove the fragment were made.The procedure was not completed due to this event.The patient was in stable condition and was discharged on (b)(6) 2024.

• Brand Name: IMAGER II ANGIOGRAPHIC CATHETER
• Common Device Name: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): TELEFLEX MEDICAL; unit 7 8 and 9; annacotty, li ; EI
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 19619618
• Report Number: 2124215-2024-38607
• Device Sequence Number: 6305624
• Product Code: DQO
• UDI-Device Identifier: 08714729354871
• UDI-Public: 08714729354871
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K121694
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/26/2024

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: 12/09/2024
• Device Model Number: 38270
• Device Catalogue Number: 38270
• Device Lot Number: 0000177222
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/06/2024
• Supplement Date Received by Manufacturer: 08/02/2024
• Initial Report FDA Received Date: 06/26/2024
• Supplement Report FDA Received Date: 08/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/09/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 59 YR
• Patient Sex: Male
• Patient Weight: 60 KG