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

Model Number	83787
Medical Device Problem Codes	Break (1069); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/05/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the coil broke during use.A 4mm x 6cm interlock.035 coil was selected for an embolization procedure.The coil was advanced into the microcatheter and after 1cm advancement became very difficult.An attempt to pull the coil back was made but did not work.The coil was noted to be cracked in the catheter.The coil and catheter were removed from the patient together.The procedure was completed with a different device.There were no patient complications.
Event or Problem Description
It was reported that the coil broke during use.A 4mm x 6cm interlock.035 coil was selected for an embolization procedure.The coil was advanced into the microcatheter and after 1cm advancement became very difficult.An attempt to pull the coil back was made but did not work.The coil was noted to be cracked in the catheter.The coil and catheter were removed from the patient together.The procedure was completed with a different device.There were no patient complications.
Additional Manufacturer Narrative
Device evaluated by mfr: the complaint device was returned with a non-bsc catheter and introducer sheath.A visual inspection of the delivery wire and coil was performed.The coil and delivery wire arms were not interlocked within the introducer sheath.The twist lock of the introducer sheath was found opened.The coil fiber bundles had blood on them.The introducer sheath was inspected and no anomalies were noted.The delivery wire was inspected and no anomalies were noted.The coil interlocking arm was found detached from the rest of the coil, in addition it was not returned.The coil was returned stretched near the interlocking arm end.A microscopic inspection of the delivery wire found the zap tip has a smooth surface.The interlocking arm was inspected and no anomalies were noted.A microscopic inspection of the main coil found the zap tip has a smooth surface.The coil interlocking arm was found detached from the rest of the coil, in addition it was not returned.A dimensional inspection of the delivery wire and mail coil was performed and found to meet specification.A labeling review was performed and it was determined that the device was not used in accordance with the dfu in two instances.The dfu states: "the interlock - 35 fibered idc occlusion system is designed to be delivered under fluoroscopy through a 5f (1.70 mm) od (0.035 in [0.89 mm] or 0.038 in [0.97 mm] inner lumen) imager ii selective diagnostic catheter without side flushing holes." the complaint indicates a non-bsc catheter was used "in order to achieve optimal performance of the interlock - 35 fibered idc occlusion system and reduce the risk of thromboembolic complications, it is critical that the 5f imager ii selective diagnostic catheter is flushed vigorously, either utilizing a continuous flush or hand injection setup, before and after the introduction of each interlock - 35 fibered idc occlusion system." device analysis found residues of blood observed in the coil fiber bundles indicating that insufficient flush was performed.

• 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: 8575115
• Report Number: 2134265-2019-04780
• Device Sequence Number: 16206827
• Product Code: KRD
• UDI-Device Identifier: 08714729792994
• UDI-Public: 08714729792994
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K110295
• 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): 06/26/2019

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: 03/31/2020
• Device Model Number: 83787
• Device Catalogue Number: 83787
• Device Lot Number: 0020386938
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/14/2019
• Initial Date Received by Manufacturer: 04/05/2019
• Supplement Date Received by Manufacturer: 06/10/2019
• Initial Report FDA Received Date: 05/02/2019
• Supplement Report FDA Received Date: 06/26/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1