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

Model Number	83786
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/28/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the coil protruded in the catheter's tip during removal.Vascular access was via the right inguinal by ipsilateral antegrade approach.The target lesion was located in a mildly tortuous and non calcified right internal iliac.A 12mm x 20cm.035 interlock coil was selected for use for a stent graft of an abdominal aortic aneurysm.During the procedure, it was noted that the coil became stuck in the area where tip of the coil was slightly extended for the distal part of the microcatheter.Furthermore, during removal, the coil protruded from the tip of the catheter.The coil was simply removed and the procedure was completed with another of the same device.No patient complications were reported and patient was good post procedure.
Event or Problem Description
It was reported that the coil protruded in the catheter's tip during removal.Vascular access was via the right inguinal by ipsilateral antegrade approach.The target lesion was located in a mildly tortuous and non calcified right internal iliac.A 12mm x 20cm.035 interlock coil was selected for use for a stent graft of an abdominal aortic aneurysm.During the procedure, it was noted that the coil became stuck in the area where tip of the coil was slightly extended for the distal part of the microcatheter.Furthermore, during removal, the coil protruded from the tip of the catheter.The coil was simply removed and the procedure was completed with another of the same device.No patient complications were reported and patient was good post procedure.
Additional Manufacturer Narrative
Device evaluated by mfr: the device was returned for evaluation.A delivery wire, coil and introducer sheath were returned for this complaint.The coil and delivery wire arms were interlocked.The twist lock of the introducer sheath had been opened.Residues of blood were noted within the introducer sheath.The delivery wire was inspected and no anomalies were noted.The coil was inspected and it was found kinked and stretched.The main coil was advanced through the introducer sheath without problems, no resistance was felt.The zap tip has a smooth surface.The interlocking arm was inspected and no anomalies was noted.The zap tip has a smooth surface.The interlocking arm was inspected and no anomalies was noted.Dimensional inspection of the delivery wire and main coil revealed the components were within specifications.

• 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: 9720506
• Report Number: 2134265-2020-01569
• Device Sequence Number: 329635
• Product Code: KRD
• UDI-Device Identifier: 08714729793175
• UDI-Public: 08714729793175
• 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,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/30/2020

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: 03/26/2022
• Device Model Number: 83786
• Device Catalogue Number: 83786
• Device Lot Number: 0023548819
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/14/2020
• Initial Date Received by Manufacturer: 01/28/2020
• Supplement Date Received by Manufacturer: 03/15/2020
• Initial Report FDA Received Date: 02/18/2020
• Supplement Report FDA Received Date: 03/30/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: COOK RIM CATHETER; COOK RIM CATHETER; DESTINATION INTRODUCER SHEATH; DESTINATION INTRODUCER SHEATH