MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SYSTEM ACCESSORY; SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC

Model Number	8815
Medical Device Problem Codes	Contamination (1120); Unsealed Device Packaging (1444)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/20/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the device sterility was compromised.The stenosed target lesion was located in the left anterior descending artery.A system accessory, which was part of an ilab ultrasound imaging system, was used for intravascular ultrasound (ivus) examination of the target lesion.During preparation, when the outer package was opened, it was found that the inner package was incomplete and the sled was not sterile, making it unusable.The procedure was completed with another of same device.The patients condition following the procedure was stable.
Additional Manufacturer Narrative
H6 device codes: corrected.
Event or Problem Description
It was reported that the device sterility was compromised.The stenosed target lesion was located in the left anterior descending artery.A system accessory, which was part of an ilab ultrasound imaging system, was used for intravascular ultrasound (ivus) examination of the target lesion.During preparation, when the outer package was opened, it was found that the inner package was incomplete and the sled was not sterile, making it unusable.The procedure was completed with another of same device.The patients condition following the procedure was stable.
Additional Manufacturer Narrative
The device was returned for analysis with no packaging.The disposable sled passed visual inspection and there were no defects on the device.
Event or Problem Description
It was reported that the device sterility was compromised.The stenosed target lesion was located in the left anterior descending artery.A system accessory, which was part of an ilab ultrasound imaging system, was used for intravascular ultrasound (ivus) examination of the target lesion.During preparation, when the outer package was opened, it was found that the inner package was incomplete and the sled was not sterile, making it unusable.The procedure was completed with another of same device.The patients condition following the procedure was stable.

• 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: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 20675776
• Report Number: 2124215-2024-71141
• Device Sequence Number: 9161733
• Product Code: DQK
• UDI-Device Identifier: 08714729228684
• UDI-Public: 08714729228684
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K151613
• 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,Followup
• Report Date (Section B): 12/26/2024

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: 04/15/2025
• Device Model Number: 8815
• Device Catalogue Number: 8815
• Device Lot Number: S1008236
• 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: 10/25/2024
• Supplement Date Received by Manufacturer: 11/19/2024; 12/16/2024
• Initial Report FDA Received Date: 11/13/2024
• Supplement Report FDA Received Date: 11/27/2024; 12/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/15/2024
• 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 Age: 66 YR
• Patient Sex: Female
• Patient Weight: 52 KG