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

Model Number	83787
Medical Device Problem Code	Stretched (1601)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/15/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Reportable based on the device analysis completed on (b)(6) 2023.It was reported that the coil was damaged.The target lesion was located in the moderately tortuous vein.A 10mm x 25cm interlock-35 was selected for use.During the procedure, it was noted that the distal part of the coil got damaged inside the catheter.Per physician's comment, it might be caused by a compatibility with the catheter, and the inside of the catheter might have been damaged as multiple catheters were used.The coil was removed together with the catheter from the body.The procedure was completed with another interlock-35.There were no complications reported and the patient was stable post procedure.However, the device analysis revealed that the coil detached at the coil arm section.
Additional Manufacturer Narrative
Device evaluated by manufacturer: the device was returned for analysis.The main coil was returned stuck inside of a non-boston scientific catheter and the main coil was observed stretched and detached at the coil arm section.A part of the original box was returned, and it was observed that the pouch information matches with the complaint information.Under the microscope it was observed that the main coil was stretched and detached at the coil arm section.

• 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 CORK LIMITED; model farm road; cork ; EI
• Manufacturer Contact: jeff wallner ; 4100 hamline ave n; arden hills, MN 55112 ; 6515811560
• MDR Report Key: 16941992
• Report Number: 2124215-2023-20768
• Device Sequence Number: 12491609
• Product Code: KRD
• UDI-Device Identifier: 08714729793106
• UDI-Public: 08714729793106
• 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
• Report Date (Section B): 05/16/2023

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: 12/06/2025
• Device Model Number: 83787
• Device Catalogue Number: 83787
• Device Lot Number: 0030667954
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/11/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/20/2023
• Initial Report FDA Received Date: 05/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/07/2022
• 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
• Patient Sex: Unknown