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

Model Number	83779
Medical Device Problem Codes	Entrapment of Device (1212); Difficult to Remove (1528); Stretched (1601)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/12/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluated by mfr: the device was returned for evaluation.Visual inspection revealed that a pusher wire and introducer sheath were returned for this complaint.The twist lock of the introducer sheath had been opened.The introducer sheath was inspected and no anomalies was noted.The pusher wire was inspected and was found kinked and stretched.The interlocking arm of the pusher wire was inspected and it was detached.No more damages were found.Functional inspection revealed that the pusher wire was advanced through the introducer sheath without problems, no resistance was felt.Microscopic inspection of the pusher wire revealed that the proximal end has a smooth surface.The interlocking arm was inspected and it was detached.Dimensional inspection of the pusher wire that could be measured were the distal and proximal outer dimeter.The inspection revealed the components were within specification.
Event or Problem Description
Reportable based on device analysis completed on 29sep2020.It was reported that resistance was felt upon withdrawal of half of the coil and it was stretched.The target lesion was located in the pulmonary artery.A 3mmx12cm interlock coil was selected for use.During procedure, it was noted that device position was not good.The physician withdrew the coil, however there was resistance when withdrawing half of the coil and the coil delivery device was stretched.The sheath was also tight against the micro catheter.The device was successfully removed from the patient's body and the procedure was completed with another of same device.No patient complications were reported and the patient was stable post procedure.However, device analysis revealed that the interlocking arm of the pusher wire was detached.

• 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: 10672916
• Report Number: 2134265-2020-14048
• Device Sequence Number: 2948477
• Product Code: KRD
• UDI-Device Identifier: 08714729764946
• UDI-Public: 08714729764946
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K132578
• 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): 10/13/2020

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: 08/27/2020
• Device Model Number: 83779
• Device Catalogue Number: 83779
• Device Lot Number: 0021185320
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/05/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/29/2020
• Initial Report FDA Received Date: 10/13/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 65 YR
• Patient Weight: 72