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

Model Number	83786
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/30/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluated by manufacturer: the device was returned for analysis.Introducer sheath and main coil were returned for this complaint.Delivery wire was not returned.The coil returned stuck in the introducer sheath.The introducer sheath was returned, and it was noticed damaged.The main coil was found kinked and severely stretched.Microscopic inspection of the main coil was performed and observed that the zap tip has a smooth surface.The interlocking arm was inspected, and it was detached.Dimensional inspection of the main coil that could be measure were performed and observed that the outer diameter (od) of the zap tip and primary coil were within specifications.However, the no.Of distal and proximal fiber bundles were lacking.
Event or Problem Description
Reportable based on device analysis completed on (b)(6) 2021.It was noted that the coil could not be pushed from the protection sheath.The target lesion was located in the internal iliac artery.A 15mm x 40cm interlock-35 was selected for use.During the procedure, four coils were used altogether.After releasing the second coil, it could not be pushed from the protection sheath and still did not work after trying repeatedly.The procedure was completed with another of the same device.There were no complications reported and patient was stable post procedure.However, device analysis revealed that the interlocking arm was detached, and fiber bundles were lacking.
Additional Manufacturer Narrative
Device evaluated by manufacturer: the device was returned for analysis.Introducer sheath and main coil were returned for this complaint.Delivery wire was returned, and no damages were noticed.The coil returned stuck in the introducer sheath.The introducer sheath was returned, and it was noticed damaged.The main coil was found kinked and severely stretched.Microscopic inspection of the main coil was performed and observed that the zap tip has a smooth surface.The interlocking arm was inspected, and it was detached.Dimensional inspection of the main coil that could be measure were performed and observed that the outer diameter (od) of the zap tip and primary coil were within specifications.However, the no.Of distal and proximal fiber bundles were lacking.
Event or Problem Description
Reportable based on device analysis completed on 24sep2021.It was noted that the coil could not be pushed from the protection sheath.The target lesion was located in the internal iliac artery.A 15mm x 40cm interlock-35 was selected for use.During the procedure, four coils were used altogether.After releasing the second coil, it could not be pushed from the protection sheath and still did not work after trying repeatedly.The procedure was completed with another of the same device.There were no complications reported and patient was stable post procedure.However, device analysis revealed that the interlocking arm was detached, and fiber bundles were lacking.

• 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: 12644441
• Report Number: 2134265-2021-12898
• Device Sequence Number: 1427983
• Product Code: KRD
• UDI-Device Identifier: 08714729793144
• UDI-Public: 08714729793144
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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,Followup
• Report Date (Section B): 11/04/2021

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: 11/17/2023
• Device Model Number: 83786
• Device Catalogue Number: 83786
• Device Lot Number: 0026378795
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/15/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/24/2021
• Supplement Date Received by Manufacturer: 10/18/2021
• Initial Report FDA Received Date: 10/17/2021
• Supplement Report FDA Received Date: 11/07/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/17/2020
• 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 Age: 58 YR
• Patient Sex: Male
• Patient Weight: 75 KG