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	06/10/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).Device evaluated by manufacturer: the device was returned for analysis.Visual inspection was performed.The coil did not return.Just returned the pusher wire.The pusher wire was severely kinked along the wire and broken at the distal end.Microscopic inspection was performed on pusher wire.The proximal end has a smooth surface.The interlocking arm was inspected, and no damages were found.Dimensional inspection on the pusher wire revealed that the distal solder joint outer dimention (o.D), mid solder joint o.D., distal tfe o.D., proximal tfe o.D.Were within specification.The length of the pusher wire is 175cm the wire was broken at 137.16 cm but return complete (both parts both parts added gave us the 175cm).
Event or Problem Description
Reportable based on device analysis completed on 11aug2021.It was reported that coil was stuck inside the microcatheter.The target lesion was located in the varicocele area.A 14mm x 50cm interlock coil was selected for use.During the preparation, the coil got stuck inside the microcatheter.Flushing was performed continuously prior to removing the entire catheter assembly.The procedure was completed with another of same device.No patient complications were reported and the patient was stable post procedure.However, the device analysis revealed a broken pusher wire at the proximal end.It was further reported that the pusher wire was severely kinked along the wire and was broken 137.16 cm at the distal end.

• 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: 12436701
• Report Number: 2134265-2021-10512
• Device Sequence Number: 3515859
• Product Code: KRD
• UDI-Device Identifier: 08714729845294
• UDI-Public: 08714729845294
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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
• Report Date (Section B): 09/07/2021

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: 12/20/2023
• Device Model Number: 83779
• Device Catalogue Number: 83779
• Device Lot Number: 0026657345
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/28/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/11/2021
• Initial Report FDA Received Date: 09/07/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 79 YR
• Patient Weight: 67