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

Model Number	83786
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/08/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the device was spilt into two.A 10mm x 20cm interlock-35 was selected for use.The proximal end of the coil was noted to be splitting into two, consequently preventing the insertion of the device into the introducer sheath.The procedure was then completed by changing the coil.There were no patient complications reported.
Additional Manufacturer Narrative
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 inside the introducer sheath.The introducer sheath was inspected and no anomalies were noted, the twist lock had been opened.The pusher wire did not show damages/abnormalities.The main coil was found in good condition, no damages were encountered.The main coil was advanced through the introducer sheath and no resistance was felt, it was deployed without problems.
Event or Problem Description
It was reported that the device was spilt into two.A 10mm x 20cm interlock-35 was selected for use.The proximal end of the coil was noted to be splitting into two, consequently preventing the insertion of the device into the introducer sheath.The procedure was then completed by changing the coil.There were no patient 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
• MDR Report Key: 8331938
• Report Number: 2134265-2019-01089
• Device Sequence Number: 1650239
• Product Code: KRD
• UDI-Device Identifier: 08714729793137
• UDI-Public: 08714729793137
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K133208
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/20/2019

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: 10/25/2021
• Device Model Number: 83786
• Device Catalogue Number: 83786
• Device Lot Number: 0022849080
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/18/2019
• Initial Date Received by Manufacturer: 01/21/2019
• Supplement Date Received by Manufacturer: 02/26/2019
• Initial Report FDA Received Date: 02/12/2019
• Supplement Report FDA Received Date: 03/20/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1