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); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/10/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluated by mfr: the device was returned for evaluation.The main coil, the pusher wire, the introducer sheath and the rotating hemostatic valve (rhv) were returned for this complaint.The coil and the interlocking arm were not interlocked within the introducer sheath.Introducer sheath and pusher wire were returned inspected, and no damages were observed.The main coil was found kinked and stretched.No more damage was found.Dimensional inspection of the main coil and pusher wire revealed the components were within specification except the number of fiber bundles, which were only 27 out of 30.No other issues were identified during the product analysis.
Event or Problem Description
Reportable based on device analysis completed on (b)(6)2022.It was reported that the coil could not be pushed out of the catheter, was self-deploying in the sheath, was unable to form good shape and the length was much longer than 30cm.The target lesion was located in the right renal aneurysm.A 14mm x 30cm interlock was selected for use.During the procedure, it was noted that that the coil could not be pushed out of the catheter and was self-deploying in the sheath.After withdrawn from the body, it was found that the coil outside the body was unable to form good shape and the length was much longer than 30cm.The entire catheter was removed and the procedure was completed with another of the same device.No complications were reported and patient was stable post procedure.However, device analysis revealed that there was fiber loss.

• Brand Name: INTERLOCK
• 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: 15680703
• Report Number: 2124215-2022-41677
• Device Sequence Number: 6368935
• Product Code: KRD
• UDI-Device Identifier: 08714729765073
• UDI-Public: 08714729765073
• 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: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/27/2022

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: 12/02/2024
• Device Model Number: 83779
• Device Catalogue Number: 83779
• Device Lot Number: 0028615687
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/15/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/06/2022
• Initial Report FDA Received Date: 10/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/02/2022
• 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