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

Model Number	83787
Medical Device Problem Codes	Difficult to Remove (1528); Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/27/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluated by mfr: the device was returned for evaluation.Visual inspection revealed that the introducer sheath was kinked at twist lock section.Also, the twist lock was opened.Blood was noticed inside the introducer sheath.The main coil and delivery wire arms were not interlocked inside the introducer sheath.The delivery wire was inspected, and no anomalies were noted.The main coil was found kinked and stretched.The customer attached pictures of the device, and it was observed that the box was opened and the device was inside the protective hoop.Microscopic inspection confirmed the interlocking arm of the main coil was detached.
Event or Problem Description
Reportable based on device analysis completed on 04jul2022.It was reported that the coil unable to advance in catheter.The target location was located in the internal iliac artery.A 10mm x 25cm interlock-35 was selected for use.During the procedure, it was noted that the coil was unable to advance in catheter and was unable to withdraw from it.The entire catheter was then removed and the procedure was completed with another of same device.No complications were reported and patient was stable post procedure.However, device analysis 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 ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 15129476
• Report Number: 2134265-2022-08105
• Device Sequence Number: 5399733
• Product Code: KRD
• UDI-Device Identifier: 08714729793106
• UDI-Public: 08714729793106
• 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): 07/29/2022

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: 11/03/2023
• Device Model Number: 83787
• Device Catalogue Number: 83787
• Device Lot Number: 0026295356
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/27/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/04/2022
• Initial Report FDA Received Date: 07/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/03/2020
• 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
• Concomitant Medical Products and Therapy/Usage Dates: DELIVERY CATHETER: CORDIS 5F CATHETER
• Patient Age: 65 YR
• Patient Sex: Male
• Patient Weight: 74 KG