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

Model Number	83779
Medical Device Problem Codes	Premature Activation (1484); Difficult to Remove (1528); Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/01/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1-initial reporter facility name: (b)(6).Device evaluated by manufacturer: the device was returned for analysis.The pouch was returned, and it was observed that the pouch information matches with the complaint information.Only the main coil was returned for the analysis, and it was totally bent and stretched, and it was observed detached at the zap tip and coil arm section.No more damages were observed.The functional inspection could not be performed due only the main coil was returned for the analysis.
Event or Problem Description
Reportable based on device analysis completed on 07nov2023.It was reported that the coil could not advance and withdrawn from the catheter.The target lesion was located in the pulmonary arteriovenous.A 4mmx15cm interlock coil was selected for use.During the procedure, when the second coil was deployed, it was noted that the coil could not advance in the middle of the catheter and was difficult to remove.After repeated adjustment, the coil got dislodged in the catheter.The coil was removed together with the catheter 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 coil detached at the zap tip and coil arm section.

• Brand Name: INTERLOCK
• 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 CORK LIMITED; 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: 18232006
• Report Number: 2124215-2023-63778
• Device Sequence Number: 14247294
• Product Code: KRD
• UDI-Device Identifier: 08714729764960
• UDI-Public: 08714729764960
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K132578
• 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
• Report Date (Section B): 11/29/2023

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: 05/03/2024
• Device Model Number: 83779
• Device Catalogue Number: 83779
• Device Lot Number: 0027428965
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/17/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/29/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/03/2021
• 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
• Patient Age: 65 YR
• Patient Sex: Male
• Patient Weight: 68 KG