MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION 2D HELICAL - 35; DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION

Model Number	82885
Medical Device Problem Code	Tear, Rip or Hole in Device Packaging (2385)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/28/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a device package was damaged and contaminated.A 3mm x 40mm (1) 2d helical 35 was selected for use.Upon unpacking, it was noted that the delivery shaft of the device became exposed out of the package and was contaminated.Furthermore, the seal was observed to be damaged.The procedure was completed with another of the same device.No patient complications reported and the patient's condition was stable.
Additional Manufacturer Narrative
Device evaluated by manufacturer: the device was returned for analysis.A coil plunger, coil introducer, retaining clip and a coil were returned for this complaint; however, the package of the device was not returned.The coil returned loaded within the coil introducer and secured by the retaining clip.The entire device was inspected and no anomalies were noted.
Event or Problem Description
It was reported that a device package was damaged and contaminated.A 3mm x 40mm (1) 2d helical 35 was selected for use.Upon unpacking, it was noted that the delivery shaft of the device became exposed out of the package and was contaminated.Furthermore, the seal was observed to be damaged.The procedure was completed with another of the same device.No patient complications reported and the patient's condition was stable.

• Brand Name: 2D HELICAL - 35
• Common Device Name: DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 8807360
• Report Number: 2134265-2019-08484
• Device Sequence Number: 327129
• Product Code: KRD
• UDI-Device Identifier: 08714729237211
• UDI-Public: 08714729237211
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K102714
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/05/2019

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: 08/31/2019
• Device Model Number: 82885
• Device Catalogue Number: 82885
• Device Lot Number: 0019650075
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/19/2019
• Initial Date Received by Manufacturer: 06/28/2019
• Supplement Date Received by Manufacturer: 08/19/2019
• Initial Report FDA Received Date: 07/19/2019
• Supplement Report FDA Received Date: 09/05/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 4 YR
• Patient Weight: 15