MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION System Accessory; system, imaging, pulsed echo, ultrasonic

Model Number	8815
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/22/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that loss of sterility occurred.A system accessory pullback sled was used to perform controlled imaging of the target lesion using an intravascular ultrasound catheter.During test period, the entire assembly had become unsterile along with the catheter post-opening.No patient complications were reported.
Additional Manufacturer Narrative
Detailed event description was not provided to bsc.A good faith effort will be made to obtain the relevant details regarding the reported complaint.If additional information becomes available, a supplemental report will be submitted.
Event or Problem Description
It was reported that loss of sterility occurred.A system accessory pullback sled was used to perform controlled imaging of the target lesion using an intravascular ultrasound catheter.During test period, the entire assembly had become unsterile along with the catheter post-opening.No patient complications were reported.
Additional Manufacturer Narrative
Investigation results: device analysis findings: visual, functional and device to device analysis found no issues, or visual defects.The sled functioned correctly.Investigation conclusion: a thorough review of the available information in the complaint did not find any fault condition(s) with the product related to the reported complaint allegation.The disposable sled passed all analysis and there were no issues found.The investigation conclusion code of no problem detected was selected.

• Brand Name: System Accessory
• Common Device Name: system, imaging, pulsed echo, ultrasonic
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): SCIENTIFIC MOLDING CORP LTD; 3250 brickway blvd; santa rosa CA 95403
• Manufacturer Contact: mark mischke ; 4100 hamline ave n; arden hills, MN 55112 ; +1(763)494-1632
• MDR Report Key: 23531347
• Report Number: 2124215-2025-81507
• Device Sequence Number: 9065855
• Product Code: DQK
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K151613
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 08/17/2026

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: 04/03/2026
• Device Model Number: 8815
• Device Catalogue Number: 8815
• Device Lot Number: S1009201
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 05/12/2026
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/18/2025
• Supplement Date Received by Manufacturer: 07/23/2026
• Initial Report FDA Received Date: 11/12/2025
• Supplement Report FDA Received Date: 08/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/03/2025
• 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
• Patient Sex: Unknown