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

Model Number	83786
Medical Device Problem Codes	Break (1069); Premature Activation (1484); Stretched (1601); Failure to Advance (2524); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/11/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial reporter address 1: (b)(6).Device evaluated by manufacturer: the device was not returned, nevertheless the customer attached pictures of the device in a pouch, and in the first picture was observed that the pouch information matches with the complaint information.In other pictures were observed that the main coil was stretched.Also, blood was observed in the main coil fibers.No more damages were identified.
Event or Problem Description
It was reported that the interlocking arm got detached.A 8mmx40cm interlock-35 was selected for use.During the procedure, physician encountered resistance when inserting and advancing the coil into the catheter.The physician tried to retract the coil from the catheter, but the coil was deployed inside the catheter.Therefore, the catheter was removed from the patient and the coil was retrieved.After examining the coil in the sterile table, the interlocking system seems broken, stretched and crinkled.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
• Manufacturer (Section G): BOSTON SCIENTIFIC CORK LIMITED; model farm road; cork ; EI
• Manufacturer Contact: jay johnson ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 16496235
• Report Number: 2124215-2023-08280
• Device Sequence Number: 6610971
• Product Code: KRD
• UDI-Device Identifier: 08714729793045
• UDI-Public: 08714729793045
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 03/07/2023

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: 07/06/2025
• Device Model Number: 83786
• Device Catalogue Number: 83786
• Device Lot Number: 0029720154
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/11/2023
• Initial Report FDA Received Date: 03/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/07/2022
• 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 Age: 33 YR
• Patient Sex: Female
• Patient Weight: 112 KG
• Patient Race: White