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	09/09/2021
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 at catheter's tip.The target lesion was located in the lumbar artery.A 3mmx12cm interlock was selected for use.During the procedure, it was noted that the coil got stuck when the tip of the coil was inserted few centimeters into the blood vessel and was protruding from the catheter's tip.A pullback was able to perform and only the coil was removed.The procedure was completed with another of the same device.No patient complications reported.
Event or Problem Description
It was reported that the coil protruded at catheter's tip.The target lesion was located in the lumbar artery.A 3mmx12cm interlock was selected for use.During the procedure, it was noted that the coil got stuck when the tip of the coil was inserted few centimeters into the blood vessel and was protruding from the catheter's tip.A pullback was able to perform and only the coil was removed.The procedure was completed with another of the same device.No patient complications reported.
Additional Manufacturer Narrative
E1 - initial reporter facility name: (b)(6).E1: initial reporter city: (b)(6).Device evaluated by manufacturer: the device was returned for analysis.Main coil, pusher wire, and introducer sheath were returned for this complaint.Main coil and pusher wire were interlocked within introducer sheath.The introducer sheath was inspected, and no anomalies were noted, an important amount of blood were noticed.The pusher wire was inspected, and it was bent at distal end.No damages were observed on the returned coil.No more damages were found in the returned device.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 pulled out backwards in order to release the main coil.Microscopic inspection of the pusher wire was performed and observed that the proximal end has a smooth surface.The interlocking arm was inspected, and no anomalies was noticed.Microscopic inspection of the main coil was performed and observed that the zap tip has a smooth surface.The interlocking arm was inspected, and no anomalies were noticed.Dimensional inspection of the pusher wire and main coil that could be measured were performed and were within specifications.

• 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 CORK LIMITED; model farm road; cork ; EI
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 12561727
• Report Number: 2134265-2021-12258
• Device Sequence Number: 1428937
• Product Code: KRD
• UDI-Device Identifier: 08714729764946
• UDI-Public: 08714729764946
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/01/2021

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: 02/28/2024
• Device Model Number: 83779
• Device Catalogue Number: 83779
• Device Lot Number: 0027058788
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/10/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/10/2021
• Supplement Date Received by Manufacturer: 11/17/2021
• Initial Report FDA Received Date: 10/01/2021
• Supplement Report FDA Received Date: 12/01/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/30/2021
• 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
• Patient Sex: Unknown