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

Model Number	83788
Medical Device Problem Codes	Entrapment of Device (1212); Separation Failure (2547)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/10/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).
Event or Problem Description
It was reported that coil protruded from the catheter tip upon removal.Vascular access was obtained via contralateral approach involving stent graft.The target lesion was located in the moderately tortuous internal iliac artery.A 4mm interlock-35 was selected for use.During procedure, the angiographic catheter was advanced however the coil could not be detached in the il detached point.Subsequently, the coil was pulled out and noted to have protruded from the catheter tip upon removal.The procedure was completed with a different device.No patient complications were reported.
Additional Manufacturer Narrative
E1.Initial reporter city: (b)(6).Device evaluated by manufacturer: the device was returned for analysis.Visual inspection was performed.The delivery and main coil were returned for this complaint.The delivery and main coil were not interlocked.The main coil was found kinked and stretched.Blood was noticed in the device.The delivery wire was inspected, and no anomalies were noted.No more damages were found in the returned device.Microscopic inspection was performed on delivery wire.The proximal end has a smooth surface.The interlocking arm was inspected, and no damages were found.Microscopic inspection was performed on the main coil.The proximal end has a smooth surface.The interlocking arm was inspected, and no damages were found.Dimensional inspection of the delivery wire and main coil that could be measured were performed and were within specifications.
Event or Problem Description
It was reported that coil protruded from the catheter tip upon removal.Vascular access was obtained via contralateral approach involving stent graft.The target lesion was located in the moderately tortuous internal iliac artery.A 4mm interlock-35 was selected for use.During procedure, the angiographic catheter was advanced however the coil could not be detached in the il detached point.Subsequently, the coil was pulled out and noted to have protruded from the catheter tip upon removal.The procedure was completed with a different device.No patient complications were reported.

• 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: 11773273
• Report Number: 2134265-2021-05553
• Device Sequence Number: 11622632
• Product Code: KRD
• UDI-Device Identifier: 08714729795483
• UDI-Public: 08714729795483
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K133208
• 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): 06/01/2021

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: 10/28/2023
• Device Model Number: 83788
• Device Catalogue Number: 83788
• Device Lot Number: 0026260870
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/28/2021
• Initial Date Received by Manufacturer: 04/13/2021
• Supplement Date Received by Manufacturer: 05/10/2021
• Initial Report FDA Received Date: 05/04/2021
• Supplement Report FDA Received Date: 06/01/2021
• 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: GUIDE CATHETER - MERIT MEDICAL; GUIDE CATHETER - MERIT MEDICAL