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

Model Number	82885
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/19/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluated by manufacturer: the device was returned for analysis.The main coil returned inside the coil introducer, also the plunger and retaining were returned.The coil introducer was inspected, and no anomalies were noted.The coil was inspected and was found kinked and stretched.No more damages were found in the device.Functional inspection was performed and observed that the main coil was stuck inside the coil introducer sheath.Microscopic inspection of the main coil was performed and observed that the base zap tip has a smooth surface, no anomalies were noticed.The apex zap tip was detached, (part did not return).Dimensional inspection of the main coil that could be measured were performed and observed that the base zap tip and outer diameter of the primary coil were within specifications.However, the apex zap tip could not be measured and there were lacking fiber bundles.
Event or Problem Description
Reportable based on device analysis completed on (b)(6) 2021.It was reported that coil failed to advance inside catheter.Vascular access was obtained via femoral artery.The target lesion was located in an artery in the liver.A 35 5 mm x 50 mm 2d helical - 35 was selected for use.During the procedure, the device could not be delivered into the angiography catheter normally and smoothly.The device was simply pulled out from the patient's body.The procedure was completed with another of same device.No complications were reported, and patient was stable post procedure.However, device analysis revealed that fiber bundles were incomplete and apex zap tip was detached.

• 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: 12285578
• Report Number: 2134265-2021-10116
• Device Sequence Number: 3130306
• Product Code: KRD
• UDI-Device Identifier: 08714729237242
• UDI-Public: 08714729237242
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/05/2021

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: 08/06/2023
• Device Model Number: 82885
• Device Catalogue Number: 82885
• Device Lot Number: 0025819329
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/05/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/15/2021
• Initial Report FDA Received Date: 08/05/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 60 YR
• Patient Weight: 62