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

Model Number	83779
Medical Device Problem Code	Premature Activation (1484)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/01/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: the event date of (b)(6) 2020 is an estimated based of the aware date of (b)(6) 2020 as the exact date was not reported.Device evaluated by manufacturer: the device was returned for analysis.A terumo catheter, the pusher wire, and the introducer sheath were returned for this complaint.The pusher wire returned inside the introducer sheath.The introducer sheath was inspected, and no anomalies were noted.The twist lock of the introducer sheath had been opened.Blood was noticed inside the introducer sheath.The pusher wire was inspected, and it was found kinked.Functional inspection revealed that the pusher wire was advanced through the introducer sheath, but it was not possible to continue advancing it was stuck, it was necessary to cut the introducer sheath in order to release the pusher wire.Microscopic inspection revealed that the proximal end of the pusher wire has a smooth surface and the interlocking arm was detached.For dimensional inspection, the overall dimension (od) of the distal solder joint, distal tfe and proximal tfe are within the specifications.The mid solder joint o.D.Could not be measured due the detached condition of the interlocking arm.
Event or Problem Description
Reportable based on device investigations completed on 20may2022.It was reported that the coil was deployed in the microcatheter.A 3mm x 12cm interlock embolics was selected for use.During deployment, the coil was deployed in the microcatheter, however, it was impossible to recover it.There were no complications reported.However, device analysis revealed that the interlocking arm was detached.

• 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: 14654953
• Report Number: 2134265-2022-06483
• Device Sequence Number: 12150221
• Product Code: KRD
• UDI-Device Identifier: 08714729764946
• UDI-Public: 08714729764946
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: Pharmacist
• Type of Report: Initial
• Report Date (Section B): 06/10/2022

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: 06/21/2023
• Device Model Number: 83779
• Device Catalogue Number: 83779
• Device Lot Number: 0025745502
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/10/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/20/2022
• Initial Report FDA Received Date: 06/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/21/2020
• 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