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

Model Number	83786
Medical Device Problem Codes	Separation Failure (2547); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/16/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluated by manufacturer: the device was returned for analysis.Visual inspection revealed that the delivery wire and introducer sheath were not returned for this complaint.The main coil was found kinked and stretched.Microscopic inspection of the main coil revealed the zap tip has a smooth surface.The interlocking arm was detached.Dimensional inspection of the main coil revealed that the number of distal and proximal fiber bundles does not match with specification.However, the overall dimension (od) of the zap tip ad primary coil matches with specifications.
Event or Problem Description
Reportable based on device analysis completed on 27jan2021.It was reported that the interlock could not be deployed in the patient's body.A 2d 15mmx40cm interlock-35 was selected for use in a recurring abdominal aortic dissection.During the procedure, the interlock could not deliver and deploy in the patient's body.The device was removed all together within the catheter and the procedure was completed with another of the same device.There were no complications reported and the patient is stable.However, device analysis revealed that the interlocking arm was detached and there are missing fiber bundles.

• Brand Name: INTERLOCK-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: 11267157
• Report Number: 2134265-2021-01056
• Device Sequence Number: 11577345
• Product Code: KRD
• UDI-Device Identifier: 08714729793144
• UDI-Public: 08714729793144
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K133208
• 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): 02/02/2021

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: 06/05/2022
• Device Model Number: 83786
• Device Catalogue Number: 83786
• Device Lot Number: 0023911178
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/21/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/27/2021
• Initial Report FDA Received Date: 02/02/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 66 YR
• Patient Weight: 76