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

Model Number	83786
Medical Device Problem Codes	Stretched (1601); Failure to Advance (2524); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/29/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Reportable based on device analysis completed on 29nov2022.It was reported that the coil could not advanced.The target lesion was located in the non-tortuous and mildly calcified left iliac arteriovenous.A 10mm x 40cm interlock-35 coil was selected for use.During the procedure, the coil could not be pushed through in the middle part of a 5f non-boston scientific catheter.After several attempts, the device was found stretched.The coil was removed directly and the procedure was completed with another of the same device.No complications were reported and the patient's status was stable.However, returned device analysis revealed the interlocking arm was found detached.
Additional Manufacturer Narrative
Device evaluated by mfr.: the device was returned for analysis.The visual inspection showed that the main coil, the delivery wire and the introducer sheath were returned.The main coil and the delivery wire were not interlocked.There was blood was noticed inside the introducer sheath.The main coil was stretched, kinked and the interlocking arm was detached.It was evidence that the introducer sheath was cut at twist lock section.The functional inspection could not be performed due the main coil and the delivery wire were not interlocked.Under microscope it was observed that the interlocking arm of the main coil was detached.Almost all device dimension passed the dimensional inspection except for the coil arm overall diameter (od) as it could not be measured due 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 ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 16018617
• Report Number: 2124215-2022-53299
• Device Sequence Number: 5784779
• Product Code: KRD
• UDI-Device Identifier: 08714729793168
• UDI-Public: 08714729793168
• 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
• Report Date (Section B): 12/20/2022

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: 04/05/2025
• Device Model Number: 83786
• Device Catalogue Number: 83786
• Device Lot Number: 0029178060
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/08/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/29/2022
• Initial Report FDA Received Date: 12/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/06/2022
• 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: 66 YR
• Patient Sex: Male
• Patient Weight: 60 KG