MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION INTERLOCK; DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION

Model Number	83779
Medical Device Problem Codes	Break (1069); Difficult to Remove (1528); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/16/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that coil break occurred.A 10mmx50cm 2d interlock coil was selected for use on the embolization of hepatic artery aneurysm.During the procedure, resistance was felt when the physician tried to remove the coil from the microcatheter.The resistance during withdrawal increased, and after forcefully pulling out the coil from the microcatheter, the coil broke within the microcatheter.The device was fully removed from the patient's body and the procedure was completed with a different device.No complications were reported and the patient was stable post procedure.
Additional Manufacturer Narrative
Device evaluated by mfr: the complaint device was received for product analysis.Only the main coil was returned.Introducer sheath and pusher wire was not returned.The coil was inspected, and it was noticed kinked and stretched.No more damages were found in the returned device.Microscopic inspection of the main coil was performed and the zap tip was inspected, and no damages were found.The interlocking arm was inspected, and no damages were found.Dimensional inspection of the main coil was performed and the measured dimensions were within specification.No other issues were identified during the product analysis.
Event or Problem Description
It was reported that coil break occurred.A 10mmx50cm 2d interlock coil was selected for use on the embolization of hepatic artery aneurysm.During the procedure, resistance was felt when the physician tried to remove the coil from the microcatheter.The resistance during withdrawal increased, and after forcefully pulling out the coil from the microcatheter, the coil broke within the microcatheter.The device was fully removed from the patient's body and the procedure was completed with a different device.No complications were reported and the patient was stable post procedure.

• Brand Name: INTERLOCK
• Common Device Name: DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORK LIMITED; model farm road; cork ; EI
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 12662525
• Report Number: 2134265-2021-13145
• Device Sequence Number: 19886610
• Product Code: KRD
• UDI-Device Identifier: 08714729765035
• UDI-Public: 08714729765035
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K132578
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/06/2022

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: 03/13/2024
• Device Model Number: 83779
• Device Catalogue Number: 83779
• Device Lot Number: 0027132710
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/02/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/28/2021
• Supplement Date Received by Manufacturer: 12/15/2021
• Initial Report FDA Received Date: 10/19/2021
• Supplement Report FDA Received Date: 01/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/13/2021
• 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
• Concomitant Medical Products and Therapy/Usage Dates: MICROCATHETER - RENEGADE STC-18; MICROCATHETER - RENEGADE STC-18; MICROCATHETER - RENEGADE STC-18
• Patient Age: 43 YR
• Patient Sex: Unknown
• Patient Weight: 70 KG