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

Model Number	83786
Medical Device Problem Codes	Premature Activation (1484); Malposition of Device (2616)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/17/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
E1 - initial reporter address 1: (b)(6).
Event or Problem Description
It was reported that the coil was retrieved by snare inside the body.The target lesion was located in the moderately tortuous and non-calcified vessel.A 12mm x 40cm interlock-35 coil and 10mm x 50cm interlock coil were selected for use.During the procedure, it was noted that the coil detached prematurely in the catheter distal part and later flowed unintentionally inside the body.The coil was completely retrieved by snare and the procedure was completed with another of the same device.There was no patient injury reported.
Event or Problem Description
It was reported that the coil was retrieved by snare inside the body.The target lesion was located in the moderately tortuous and non-calcified vessel.A 12mm x 40cm interlock-35 coil and 10mm x 50cm interlock coil were selected for use.During the procedure, it was noted that the coil detached prematurely in the catheter distal part and later flowed unintentionally inside the body.The coil was completely retrieved by snare and the procedure was completed with another of the same device.There was no patient injury reported.
Additional Manufacturer Narrative
E1 - initial reporter address 1: (b)(6) device evaluated by mfr: the complaint device was received for product analysis.Visual inspection was performed, and it was observed that the main coil, the introducer sheath and the pusher wire were returned.It was necessary to make tow cuts in the introducer wire to remove the coil.It was observed that the main coil was bent and stretched at the primary coil.Also, was detached at the arm coil section.A part of the original box was returned, and it was observed that the pouch information matches with the complaint information.No more damages were observed.The functional could not be performed due the main coil and the pusher wire are not interlocking.Dimensional inspection of the main coil revealed the components were within specifications.No other issues were identified during the product analysis.

• 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: 18268480
• Report Number: 2124215-2023-66230
• Device Sequence Number: 12727550
• Product Code: KRD
• UDI-Device Identifier: 08714729792970
• UDI-Public: 08714729792970
• 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: Other,Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/11/2024

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: 08/03/2025
• Device Model Number: 83786
• Device Catalogue Number: 83786
• Device Lot Number: 0029890441
• 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: 11/17/2023
• Supplement Date Received by Manufacturer: 12/26/2023
• Initial Report FDA Received Date: 12/05/2023
• Supplement Report FDA Received Date: 01/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/04/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: MICRO CATHETER - BREAKTHROUGH 2M; MICRO CATHETER - BREAKTHROUGH 2M
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown