MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION COIL PUSHER-16; DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION

Model Number	83785
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/31/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluated by mfr: the device was received for product analysis.Visual inspection was performed, and it was observed that the main coil was returned inside the pusher wire.It was observed that the main coil was bent and stretched at the primary coil section, moreover the main coil was detached.The pusher wire was bent and damaged.The functional could not be performed due the main coil and the pusher wire are not interlocking.No other issues were identified during the product analysis.
Event or Problem Description
Reportable based on device analysis completed on 16aug2024.A 177cm coil pusher-16 was returned with no reported issues.However, device analysis revealed that the main coil was detached.

• Brand Name: COIL PUSHER-16
• Common Device Name: DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; model farm road; cork T12 Y K88; EI T12 YK88
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 20170712
• Report Number: 2124215-2024-55268
• Device Sequence Number: 8249833
• Product Code: KRD
• UDI-Device Identifier: 08714729158967
• UDI-Public: 08714729158967
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K102714
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/09/2024

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: 10/07/2025
• Device Model Number: 83785
• Device Catalogue Number: 83785
• Device Lot Number: 0030491673
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/31/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/16/2024
• Initial Report FDA Received Date: 09/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/07/2022
• 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