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

Model Number 83787

Device Problems Premature Activation (1484); Difficult to Remove (1528); Failure to Advance (2524); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/12/2023

Event Type  malfunction  

Event Description

Reportable based on device analysis completed on 05feb2024.It was reported that the coil could not be pushed nor withdrawn and got detached in the catheter.Interlock-35 coil was selected for use.During the procedure, when the coil was advanced into a non-boston scientific catheter, it was noted that it was very dry and astringent.When the coil had been pushed into the patient for half, the guidewire could not move forward.During the recapture, it was found that the device could not be withdrawn to the protective sheath, and after it was withdrawn completely, the coil was detached.The procedure was completed with another of the same device.No complications were reported and the patient was stable post-procedure.However, device analysis revealed that the main coil was detached at the coil arm section.

Manufacturer Narrative

E1 - initial reporter facility name: (b)(6).Device evaluated by mfr: the complaint device was received for product analysis.A visual inspection was performed and it was observed that the main coil, the introducer sheath and the delivery wire were returned.It was observed that the main coil was bent, detached and stretched 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.No more damages were observed during visual inspection.The functional inspection could not be performed due to 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
• Type of Device: 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: 18767860
• MDR Text Key: 336615301
• Report Number: 2124215-2024-07941
• Device Sequence Number: 1
• Product Code: KRD
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K133208
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/23/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 83787
• Device Catalogue Number: 83787
• Device Lot Number: 0032187679
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/18/2024
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/05/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/10/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 71 YR
• Patient Sex: Female