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

Model Number	83786
Medical Device Problem Codes	Malposition of Device (2616); Positioning Problem (3009); Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
B3: date of event: no date provided, used the first date in the month of the aware date.
Event or Problem Description
It was reported that malposition occurred requiring additional intervention.A 15mm x 40cm interlock-35 was selected for a pelvic vein embolization procedure.During the procedure, the tip of the catheter migrated into the right atrium following the release of the interlock-35 coil.The physician attempted to recover the device using a snare but failed.The patient was referred to a cardiologist for another attempt with an introducer in place.
Additional Manufacturer Narrative
B3: date of event: no date provided, used the first date in the month of the aware date.H6: device codes (1): updated from malposition of device and positioning problem to migration.
Event or Problem Description
It was reported that malposition occurred requiring additional intervention.A 15mm x 40cm interlock-35 was selected for a pelvic vein embolization procedure.During the procedure, the tip of the catheter migrated into the right atrium following the release of the interlock-35 coil.The physician attempted to recover the device using a snare but failed.The patient was referred to a cardiologist for another attempt with an introducer in place.It was further reported that the coil migrated and not the tip of the catheter as previously reported.

• Brand Name: INTERLOCK-35
• Common Device Name: DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; model farm road; cork T12 Y K88; EI T12 YK88
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 18662246
• Report Number: 2124215-2024-05286
• Device Sequence Number: 8063672
• Product Code: KRD
• UDI-Device Identifier: 08714729793144
• UDI-Public: 08714729793144
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 05/06/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/15/2026
• Device Model Number: 83786
• Device Catalogue Number: 83786
• Device Lot Number: 0032225646
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/26/2024
• Supplement Date Received by Manufacturer: 05/02/2024
• Initial Report FDA Received Date: 02/07/2024
• Supplement Report FDA Received Date: 05/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/16/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown