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

Model Number	83786
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/20/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).Device evaluated by manufacturer: the device was returned for analysis.A delivery wire, main coil and introducer sheath were returned for this complaint.The coil and delivery wire arms were interlocked within introducer sheath.The introducer sheath was inspected, and no anomalies were noted, the twist lock had been opened.An important amount of blood was noted inside the introducer sheath and on the main coil.The main coil was found kinked and stretched.The delivery wire was inspected, and no anomalies were noted.No more damages were found in the returned device.The delivery 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.Microscopic inspection of the delivery wire was performed and observed that the zap tip has a smooth surface.The interlocking arm was inspected, and no anomalies was noted.Microscopic inspection of the main coil was performed and observed that the zap tip has a smooth surface.The interlocking arm was detached.Dimensional inspection of the main coil and delivery wire that could be measured were performed and were within specifications.
Event or Problem Description
Reportable based on device analysis completed on 17nov2021.It was reported that the device could not be detached.The target lesion was located in the moderately tortuous vessel.A 3mm x 4cm interlock-35 was selected for use.During the procedure, it was noted that the device could not be detached.The procedure was completed with another of the same device.There were no complications reported.However, device investigations revealed that the interlocking arm was detached.

• 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
• 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: 12945181
• Report Number: 2134265-2021-14856
• Device Sequence Number: 20115609
• Product Code: KRD
• UDI-Device Identifier: 08714729793151
• UDI-Public: 08714729793151
• 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: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/06/2021

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: 04/12/2024
• Device Model Number: 83786
• Device Catalogue Number: 83786
• Device Lot Number: 0027132720
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/09/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/17/2021
• Initial Report FDA Received Date: 12/06/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/13/2021
• 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