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

Model Number	83786
Medical Device Problem Codes	Stretched (1601); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/21/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).Device evaluated by mfr: the device was returned for evaluation.Visual inspection revealed that the main coil was found kinked and stretched.Microscopic inspection of the main coil revealed that the zap tip has a smooth surface.The interlocking arm was inspected and no anomalies was noted.Dimensional inspection of the main coil revealed the components were within specification except the number of fiber bundles, which were only 27 out of 37-44.
Event or Problem Description
Reportable based on device analysis completed on 22oct2020.It was reported that coil friction occurred and the coil was stretched.The target area was located in the gastric vein.A 18mm x 40cm interlock -35 coil was selected for use.During procedure, it was noted that the coil could not be pushed continuously when reached half of the catheter.It was also found out that the coil was stretched.The procedure was completed with another of same device.No patient complications were reported and patient was stable post procedure.Patient was stable post procedure.However, device analysis revealed that there was 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: 10779804
• Report Number: 2134265-2020-15231
• Device Sequence Number: 1088275
• Product Code: KRD
• UDI-Device Identifier: 08714729795414
• UDI-Public: 08714729795414
• 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,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/03/2020

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: 02/12/2023
• Device Model Number: 83786
• Device Catalogue Number: 83786
• Device Lot Number: 0025203889
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/09/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/22/2020
• Initial Report FDA Received Date: 11/03/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 44 YR
• Patient Weight: 69