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

Model Number	38270
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/20/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that additional intervention was required to remove a detached tip.An imager ii angiographic catheter was selected for use in embolization of the renal artery.The condition of the vessel was a straightforward renal artery.While inserting the catheter into the patient, the distal tip detached.There was no resistance noted during use of the device.The tip migrated toward the aorta.An initial attempt at retrieval was unsuccessful because the tip had become adhered to the aortic wall.A new vascular access site was created, and a new sheath was used from the new site.When the detached tip eventually moved, it was removed from the lower part of the leg via snare.When the tip was extracted from the sheath, it had broken into small fragments.The procedure was completed with a different device.There were no patient complications as a result of the event.The patient was stable following the procedure.
Additional Manufacturer Narrative
Device technical analysis: the device was returned and analysis was completed.Visual inspection of the device revealed a detached and missing tip.Microscopic examination revealed that a detached/missing tip was observed along with a shaft fracture located at 5 mm from the tip.Nuclear magnetic resonance spectroscopy testing showed that oxidation and hydrolysis were observed, which is consistent degradation of the material when in contact with hydrogen peroxide.Device history record review: it was confirmed this device met manufacturing specifications prior to distribution and there were no manufacturing deviations that could have contributed to the reported event.Labeling review: review of the instructions for use (ifu) confirmed that the content was sufficient and did not contribute to the reported event; therefore, no updates are required to the document at the time.Risk review: a risk review performed for the imager ii angiographic catheter confirmed that the event of tip detachment of device or device component is a known event defined in the products risk management documentation.This event type has been accounted for during product risk analysis to support acceptable risk benefit for the product.Investigation conclusion: boston scientific concludes the most probable root cause as failure to follow instructions.Analysis of the returned device revealed that the imager ii angiographic catheter may have been exposed to hydrogen peroxide at the healthcare facility.The instructions for use (ifu) specifies that catheter integrity can be compromised if exposed to these substances.
Event or Problem Description
It was reported that additional intervention was required to remove a detached tip.An imager ii angiographic catheter was selected for use in embolization of the renal artery.The condition of the vessel was a straightforward renal artery.While inserting the catheter into the patient, the distal tip detached.There was no resistance noted during use of the device.The tip migrated toward the aorta.An initial attempt at retrieval was unsuccessful because the tip had become adhered to the aortic wall.A new vascular access site was created, and a new sheath was used from the new site.When the detached tip eventually moved, it was removed from the lower part of the leg via snare.When the tip was extracted from the sheath, it had broken into small fragments.The procedure was completed with a different device.There were no patient complications as a result of the event.The patient was stable following the procedure.

• 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 V94 F F83; EI V94 FF83
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 23853499
• Report Number: 2124215-2025-92106
• Device Sequence Number: 15845872
• Product Code: DQO
• UDI-Device Identifier: 08714729355403
• UDI-Public: (01)08714729355403(17)270116(10)74A2500463
• Combination Product (Y/N): N
• Initial Reporter Country: CY
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/19/2026

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 Model Number: 38270
• Device Catalogue Number: 38270
• Device Lot Number: 74A2500463
• 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: 11/24/2025
• Supplement Date Received by Manufacturer: 02/19/2026
• Initial Report FDA Received Date: 12/19/2025
• Supplement Report FDA Received Date: 03/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/17/2025
• 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: Required Intervention
• Patient Sex: Unknown