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

Model Number 83787

Device Problem Failure to Advance (2524)

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

Event Date 12/28/2023

Event Type  malfunction  

Manufacturer Narrative

E1: initial reporter facility name - (b)(6).Device evaluated by mfr: only the main coil was returned.It was observed that the main coil was bent, detached and stretched at the coil arm section.The original pouch was returned, and it was observed that the pouch information matches with the complaint information.The functional could not be performed due only the main coil was returned.Dimensional inspection of the main coil revealed the components were within specification.No other issues were identified during the product analysis.

Event Description

Reportable based on device analysis completed on (b)(6) 2024.It was reported that the coil could not be pushed out in the catheter.The target lesion was located in the splenic artery aneurysm.A 20mm x 40cm interlock-35 was selected for use.During the procedure, it was noted that the coil had resistance in the catheter and did not advance.Flushing was done, however, it still could not be deployed.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 main coil was detached.

• 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: 18887573
• MDR Text Key: 337544273
• Report Number: 2124215-2024-12488
• Device Sequence Number: 1
• Product Code: KRD
• UDI-Device Identifier: 08714729795445
• UDI-Public: 08714729795445
• 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: 03/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/12/2024
• 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: 0032089594
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/14/2024
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/23/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/26/2023
• 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
• Treatment: MICROCATHETER: CORDIS 5F
• Patient Age: 69 YR
• Patient Sex: Male
• Patient Weight: 70 KG