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

Model Number	83787
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/21/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluated by mfr.: the device was returned for evaluation.Unit returned together with a non-bsc device, overall visual revision did not identify failures or evidence that could be lost due to decontamination process.A visual inspection carried over and revealed that a delivery wire, main coil and introducer sheath were returned for this complaint.Besides, a rotating hemostatic valve (rhv) and a non-bsc catheter was returned together with the device.The main coil and delivery wire arms were not interlocked.The introducer sheath was inspected and no anomalies were noted, the twist lock had been opened.The sheath showed dry blood residues inside.The main coil was completely stretched and some sections were kinked; besides, the zap tip was detached and it was not returned, the interlocking arm was also detached, but it was returned inside the introducer sheath.A functional inspection revealed that the delivery wire was removed without issues.A microscopic inspection revealed that the proximal end of the delivery wire has a smooth surface.The interlocking arm did not show damages.The proximal end of the main coil zap tip was detached and it was not returned.The main coil was completely stretched and kinked.The interlocking arm was detached and it was found inside the introducer sheath.A dimensional inspection was revealed that weld od, wire arm od, and wire zap tip in delivery wire are within its specification.The number, of distal fiber bundles, proximal fiber bundles, zap tip od, and primary coil od are not on its specification.No other issues reported.
Event or Problem Description
Reportable based on device analysis completed on 10-jan-2019.- it was reported that a coil had difficulty in the middle of the angiographic catheter and it as unable to be placed during coil embolization.A stenosed target lesion was located at severe tortuous internal iliac artery.A 10mm x 25cm interlock-35 was selected for use.During the procedure, at coil embolization, it was noted that a coil had difficulty in the middle of the angiographic catheter and it as unable to be placed.The device was replaced with another of the same.There were no patient complications reported.However, it was further reported that the zap tip was detached and it was not returned, the interlocking arm was also detached, but it was returned inside the introducer sheath.

• 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: 8271241
• Report Number: 2134265-2019-00288
• Device Sequence Number: 10792344
• Product Code: KRD
• UDI-Device Identifier: 08714729793106
• UDI-Public: 08714729793106
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 01/23/2019

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: 08/31/2019
• Device Model Number: 83787
• Device Catalogue Number: 83787
• Device Lot Number: 0019542748
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/20/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/10/2019
• Initial Report FDA Received Date: 01/23/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1