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

Model Number	8815
Medical Device Problem Code	Unsealed Device Packaging (1444)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/01/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the device sterility was compromised.The pullback sled, a system accessory which was part of an ilab ultrasound imaging system, was selected for intravascular ultrasound (ivus) examination of the target lesion.When the outer box was opened, it was found that the seal of the inner package was cracked.The procedure was completed with another of the same device.The patients condition following the procedure was stable.
Additional Manufacturer Narrative
A2 age at time of event: 18 years or older.
Event or Problem Description
It was reported that the device sterility was compromised.The pullback sled, a system accessory which was part of an ilab ultrasound imaging system, was selected for intravascular ultrasound (ivus) examination of the target lesion.When the outer box was opened, it was found that the seal of the inner package was cracked.The procedure was completed with another of the same device.The patients condition following the procedure was stable.
Additional Manufacturer Narrative
The device was returned for analysis.Visual inspection revealed a compromised/incomplete seal.The middle of the left side and the other side had a complete seal, but it was barely there, and the sled tray appeared to have some deformities.A2 age at time of event: 18 years or older.

• 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: 20800525
• Report Number: 2124215-2024-74927
• Device Sequence Number: 7809780
• 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
• Report Date (Section B): 12/12/2024

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: 06/14/2025
• Device Model Number: 8815
• Device Catalogue Number: 8815
• Device Lot Number: S1008391
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/15/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/11/2024
• Supplement Date Received by Manufacturer: 12/02/2024
• Initial Report FDA Received Date: 11/27/2024
• Supplement Report FDA Received Date: 12/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/14/2024
• 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: Female