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

Model Number	83786
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/01/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Reportable based on device analysis completed on 05apr2021.It was reported that there was friction and the coils would not pass the tip of the catheter.A10mm x 20cm interlock.035 embolic device was selected for a procedure.During the procedure, while inside the patient, the coils would not pass the tip of the catheter.There were no patient complications reported.However, device analysis revealed the interlocking arm was detached and there were missing fiber bundles.Device evaluated by mfr: visual inspection showed that only the coil was returned for this complaint.The coil fiber bundles had blood on them.The main coil was kinked and stretched.No more damages were found in the returned device.Microscopic inspection of the main coil showed that the zap tip has a smooth surface.The interlocking arm was inspected, and it was detached.The main coil number of distal fiber bundles, zap tip outer diameter and primary coil outer diameter were within specifications, except for the number of proximal fiber bundles which was 18 out of 22-32.

• 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: 11657635
• Report Number: 2134265-2021-04791
• Device Sequence Number: 11818396
• Product Code: KRD
• UDI-Device Identifier: 08714729793137
• UDI-Public: 08714729793137
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• 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,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/13/2021

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: 09/29/2023
• Device Model Number: 83786
• Device Catalogue Number: 83786
• Device Lot Number: 0026096100
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/18/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/05/2021
• Initial Report FDA Received Date: 04/13/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1