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	09/29/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a tip detachment occurred.An imager ii angiographic catheter was selected for use.The catheter was flushed during preparation, however, the tip detached into two pieces.The same event occurred again with another imager ii angiographic catheter.The procedure was completed with a different device.There were no patient complications as a result of the event.
Additional Manufacturer Narrative
Device eval by mfr: the device was returned, and analysis was completed.The returned product consisted of an imager ii diagnostic catheter.Visual inspection of the device revealed a detached and missing tip along with a shaft kink.Microscopic inspection revealed that a detached/missing tip was observed along with three separate detached sections of the tip.An additional shaft kink was observed 31 cm from the hub.
Event or Problem Description
It was reported that a tip detachment occurred.An imager ii angiographic catheter was selected for use.The catheter was flushed during preparation, however, the tip detached into two pieces.The procedure was completed with a different device.There were no patient complications as a result of the event.
Additional Manufacturer Narrative
Device analysis: the device was returned, and analysis was completed.The returned product consisted of an imager ii diagnostic catheter.Visual inspection of the device revealed a detached and missing tip along with a shaft kink.Microscopic inspection revealed that a detached/missing tip was observed along with three separate detached sections of the tip.An additional shaft kink was observed 31 cm from the hub.Nuclear magnetic resonance spectroscopy testing was performed, and oxidation and hydrolysis were observed, which is consistent with degradation of pebax 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 product's risk management documentation.This event type has been accounted for during product risk analysis to support acceptable risk benefit for the product.Investigation conclusion: bsc assigned the referenced event the investigation conclusion code of failure to follow instructions.It was reported that the imager ii angiographic catheter may have been exposed to hydrogen peroxide in the catheterization lab.The instructions for use (ifu) indicates: "do not store this product in an area that is subject to aggressive disinfectant exposure, such as vaporized or in-solution hydrogen peroxide.Catheter integrity can be compromised if exposed to these substances.".
Event or Problem Description
It was reported that a tip detachment occurred.An imager ii angiographic catheter was selected for use.The catheter was flushed during preparation, however, the tip detached into two pieces.The procedure was completed with a different device.There were no patient complications as a result of the event.It was further reported that hydrogen peroxide was used to clean the catheterization lab once a month.

• 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: 23407634
• Report Number: 2124215-2025-72115
• Device Sequence Number: 18424816
• Product Code: DQO
• UDI-Device Identifier: 08714729355588
• UDI-Public: (01)08714729355588(17)260215(10)74B2400543
• 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,Followup
• Report Date (Section B): 03/18/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/15/2026
• Device Model Number: 38270
• Device Catalogue Number: 38270
• Device Lot Number: 74B2400543
• 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: 09/29/2025
• Supplement Date Received by Manufacturer: 12/15/2025; 02/17/2026
• Initial Report FDA Received Date: 10/28/2025
• Supplement Report FDA Received Date: 12/15/2025; 03/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/16/2024
• 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
• Patient Sex: Male