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

Model Number 83786

Device Problems Difficult to Remove (1528); Failure to Advance (2524)

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

Event Date 04/10/2023

Event Type  malfunction  

Event Description

Reportable based on device analysis completed on 07jun2023.It was reported that the coil was unable to advance.The target lesion was located in the internal iliac artery.A 8mm x 40cm.035 interlock 2d coil was selected for use.During the procedure, a non-boston scientific sheath, guidewire and 5f single curved sheath was used to delivery the coil for sufficient support.However, the coil could not be advanced from the catheter despite multiple attempts.The coil and the catheter were removed together and the procedure was completed with a different device.No complications were reported and the patient was stable.However, device analysis revealed coil detachment at the arm section.

Manufacturer Narrative

Device evaluated by mfr.: the device was returned for analysis.Visual and microscopic inspection shows only the main coil was returned for the analysis.The main coil was observed kinked, stretched and detached at the coil interlocking arm section.No more damages or issues were observed.Functional inspection could not be performed as the pusher wire was not returned, only the main coil was returned for the analysis.The device passed all dimensional inspections.

• 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 CORK LIMITED; model farm road; cork ; EI
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 17231583
• MDR Text Key: 318293724
• Report Number: 2124215-2023-29965
• Device Sequence Number: 1
• Product Code: KRD
• UDI-Device Identifier: 08714729793014
• UDI-Public: 08714729793014
• 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: 06/29/2023

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
• Device Operator: Health Professional
• Device Model Number: 83786
• Device Catalogue Number: 83786
• Device Lot Number: 0030327173
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/02/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/07/2023
• Initial Date FDA Received: 06/29/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/12/2022
• 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: 65 YR
• Patient Sex: Male