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

Model Number	83779
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/09/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial reporter address 1: (b)(6).Device evaluated by manufacturer: the device was returned for analysis.A pusher wire, the main coil and the introducer sheath were returned for this complaint.The coil and pusher wire arms were interlocked within introducer sheath.Blood was noticed inside the introducer sheath.The twist lock of the introducer sheath had been opened.The pusher wire was inspected, and it was kinked.The main coil was found kinked and stretched.The pusher wire was advanced through the introducer sheath, but it was not possible to continue advancing it because the coil was stuck, it was necessary to cut the introducer sheath in order to release the main coil.The proximal end has a smooth surface.The zap tip has a smooth surface.The dimensional inspection revealed that the outer diameter (od) at the zap tip was found to be within specification.However, fiber bundles and (oc) main coil were found to be not within specification.
Event or Problem Description
Reportable based on device analysis completed on (b)(6) 2022.It was reported that the coil could not be inserted into the catheter the target lesion was located in the mildly tortuous and mildly calcified iliac artery.A 10mm x 50cm interlock was selected for use.During the procedure, it was noted that the coil could not be inserted into the catheter so it was removed.The physician tried to reinsert the coil, however resistance was felt about 3cm before reaching the catheter.The procedure was completed with another of the same device.There were no patient complications reported.However, device analysis revealed that there were missing fiber bundles.

• Brand Name: INTERLOCK
• Common Device Name: DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; model farm road; cork ; EI
• Manufacturer Contact: johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 13978221
• Report Number: 2134265-2022-03246
• Device Sequence Number: 5567600
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/01/2022

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: 06/07/2024
• Device Model Number: 83779
• Device Catalogue Number: 83779
• Device Lot Number: 0027629429
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/23/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/11/2022
• Initial Report FDA Received Date: 04/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/08/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: BREAKTHROUGH2M- MICROCATHETER; MEDIKIT- INTRODUCER SHEATH; RADIFOCUS- GUIDEWIRE
• Patient Sex: Unknown