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

Model Number	83779
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/11/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial reporter name and address: (b)(6).
Event or Problem Description
It was reported that the coil protruded from the catheter's tip during removal.The non stenosed target lesion was located in the moderately tortuous and non calcified internal iliac artery.A 10mmx30cm and a 10mmx50cm interlock coil were selected for use.During the procedure, it was noted that the coil became stuck in the distal part of the catheter.Furthermore, when the coils were removed from the patient's body, it was noted that the devices protruded from the tip of the microcatheter.The procedure was completed with a different device.No patient complications were reported.
Event or Problem Description
It was reported that the coil protruded from the catheter's tip during removal.The non stenosed target lesion was located in the moderately tortuous and non calcified internal iliac artery.A 10mmx30cm and a 10mmx50cm interlock coil were selected for use.During the procedure, it was noted that the coil became stuck in the distal part of the catheter.Furthermore, when the coils were removed from the patient's body, it was noted that the devices protruded from the tip of the microcatheter.The procedure was completed with a different device.No patient complications were reported.
Additional Manufacturer Narrative
E1 - initial reporter address 1: (b)(6).E1 - initial reporter city: (b)(6).Device evaluated by mfr: the device was returned for evaluation.Visual inspection revealed that a pusher wire, coil, introducer sheath and a valve were returned for this complaint.The coil and pusher wire arms were interlocked within introducer sheath.The twist lock of the introducer sheath had been opened.The coil was inspected, and it was found kinked and stretched.The pusher wire was found kinked.No more damages were found in the returned device.Functional inspection revealed that the pusher wire was advanced through the introducer sheath, but it was not possible to continue advancing it because the coil was stuck, due the stretched condition.It was pulled out backwards to release the main coil.Microscopic inspection of the main coil and pusher wire revealed that the zap tip has a smooth surface.The interlocking arm was inspected, and no anomalies was noted.Dimensional inspection of the pusher wire and main coil revealed the components were within specification.

• 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: 12101065
• Report Number: 2134265-2021-08153
• Device Sequence Number: 19778764
• Product Code: KRD
• UDI-Device Identifier: 08714729845287
• UDI-Public: 08714729845287
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K132578
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/05/2021

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: 08/16/2023
• Device Model Number: 83779
• Device Catalogue Number: 83779
• Device Lot Number: 0026021642
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/07/2021
• Initial Date Received by Manufacturer: 06/12/2021
• Supplement Date Received by Manufacturer: 07/22/2021
• Initial Report FDA Received Date: 07/01/2021
• Supplement Report FDA Received Date: 08/05/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1