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

Model Number	83787
Medical Device Problem Codes	Entrapment of Device (1212); Difficult to Remove (1528); Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/09/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the coil has come out of the catheter.The target lesion was located in the moderately tortuous and non-calcified internal iliac artery.A 8mm x 20cm.035 interlock cube embolics was selected for use.During delivery of the product, a gutter was created by breaking through the wall of the catheter instead of the tip and the coil has come out of the catheter.The entire catheter was removed, however, two-thirds of the coil protruded from the tip.The procedure was completed with a different device.There were no complications reported.
Additional Manufacturer Narrative
Device evaluated by manufacturer: only the main coil was returned analysis.The main coil was kinked and stretched.No more damages were found.
Event or Problem Description
It was reported that the coil has come out of the catheter.The target lesion was located in the moderately tortuous and non-calcified internal iliac artery.A 8mm x 20cm.035 interlock cube embolics was selected for use.During delivery of the product, a gutter was created by breaking through the wall of the catheter instead of the tip and the coil has come out of the catheter.The entire catheter was removed, however, two-thirds of the coil protruded from the tip.The procedure was completed with a different device.There were no complications reported.

• 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: 14880660
• Report Number: 2134265-2022-07244
• Device Sequence Number: 5040027
• Product Code: KRD
• UDI-Device Identifier: 08714729793052
• UDI-Public: 08714729793052
• 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,Followup
• Report Date (Section B): 08/12/2022

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: 02/25/2023
• Device Model Number: 83787
• Device Catalogue Number: 83787
• Device Lot Number: 0025269719
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/09/2022
• Supplement Date Received by Manufacturer: 07/19/2022
• Initial Report FDA Received Date: 06/30/2022
• Supplement Report FDA Received Date: 08/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/26/2020
• 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: GUIDE CATHETER-4FR IMPRESS; GUIDE CATHETER-4FR IMPRESS; GUIDEWIRE-RADIFOCUS; GUIDEWIRE-RADIFOCUS
• Patient Sex: Unknown