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

Model Number	83777
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/03/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluated by mfr: the device was returned for analysis.Only the main coil was returned for this complaint.The coil was found stretched and kinked.No more damages were found in the returned device.Microscopic inspection of the main coil observed that the zap tip has a smooth surface.The interlocking arm was inspected and it was found detached.The detached part was not returned.Dimensional inspection of the main coil was performed and observed that the outer diameter (od) of the zap tip and primary coil were within specification, however there were lacking coil fiber bundles.
Event or Problem Description
Reportable based on device analysis completed on 26mar2020.It was reported that there was no coiling in the vessel.A 2/3mm x 2.3cm interlock was selected for use.During the procedure, it was noted that the device did not coil in the vessel.The procedure was completed with another of the same device.No complications reported and patient's condition was stable.However, device analysis revealed detached interlocking arm and missing coil fiber bundles.
Event or Problem Description
Reportable based on device analysis completed on 26mar2020.It was reported that there was no coiling in the vessel.A 2/3mm x 2.3cm interlock was selected for use.During the procedure, it was noted that the device did not coil in the vessel.The procedure was completed with another of the same device.No complications reported and patient's condition was stable.However, device analysis revealed detached interlocking arm and missing coil fiber bundles.It was further reported that the coil was not deployed successfully and was then retrieved safely.There were no device fragments left inside the patient's body.
Additional Manufacturer Narrative
Device evaluated by mfr: the device was returned for analysis.Only the main coil was returned for this complaint.The coil was found stretched and kinked.No more damages were found in the returned device.Microscopic inspection of the main coil observed that the zap tip has a smooth surface.The interlocking arm was inspected and it was found detached.The detached part was not returned.Dimensional inspection of the main coil was performed and observed that the outer diameter (od) of the zap tip and primary coil were within specification, however there were lacking coil fiber bundles.

• Brand Name: INTERLOCK
• Common Device Name: DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 9957747
• Report Number: 2134265-2020-05001
• Device Sequence Number: 2438296
• Product Code: KRD
• UDI-Device Identifier: 08714729765080
• UDI-Public: 08714729765080
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K132578
• 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,Followup
• Report Date (Section B): 05/01/2020

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: 11/02/2021
• Device Model Number: 83777
• Device Catalogue Number: 83777
• Device Lot Number: 0023020276
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/27/2020
• Initial Date Received by Manufacturer: 03/26/2020
• Supplement Date Received by Manufacturer: 04/16/2020
• Initial Report FDA Received Date: 04/14/2020
• Supplement Report FDA Received Date: 05/01/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 55 YR