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

Model Number	83786
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/30/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluated by the mfr: only the main coil was returned for this complaint.A non-bsc catheter was returned with the complaint.The main coil was found kinked and stretched, besides, the fiber bundles had blood residues.The main coil was advanced through the non-bsc catheter, but it was not possible to continue advancing it due to the main coil was stuck; it was necessary to cut the catheter in order to release the main coil.The delivery wire was not returned.The main coil zap tip has a smooth surface.The main coil was stretched and kinked near the interlocking arm; more stretched sections were observed along the main coil.The interlocking arm of the main coil was detached.Dimensional inspection revealed that the number of distal and proximal fiber bundles failed specification.The zap tip and primary coil outer diameter were within specifications.
Event or Problem Description
Reportable based on device analysis completed on 10oct2019.It was reported that the coil could not deploy.An 8mm x 20cm interlock coil was selected for use.During the procedure, a continuous flush was performed and the device was advanced to the middle of the 5f catheter; however it was noted that the device could not deploy.The device was removed with the catheter from the patient's body.The procedure was completed with a different device.There were no patient complications reported and the patient's condition was stable post procedure.However, device analysis revealed that there were missing fiber bundles and the interlocking arm of the main coil was detached.

• 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: 9265957
• Report Number: 2134265-2019-13204
• Device Sequence Number: 13940894
• Product Code: KRD
• UDI-Device Identifier: 08714729793045
• UDI-Public: 08714729793045
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K133208
• 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
• Report Date (Section B): 11/01/2019

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: 01/14/2022
• Device Model Number: 83786
• Device Catalogue Number: 83786
• Device Lot Number: 0023189222
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/19/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/10/2019
• Initial Report FDA Received Date: 11/01/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 45 YR
• Patient Weight: 70