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

Model Number 83787

Device Problems Break (1069); Difficult to Remove (1528); Stretched (1601); Failure to Advance (2524)

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

Event Date 09/07/2023

Event Type  malfunction  

Event Description

It was reported that the coil was fractured.The target lesion was located in the splenic artery with multiple aortic aneurysms.A 10mm x 40cm.035 interlock cube coil was selected for use.During the procedure, the device was delivered normally into the non-boston scientific contrast catheter.However, when the physician continued to push the coil, the coil got stuck and broke at the opening of the contrast catheter.The coil could not be pulled back.The physician withdraws the coil together with the delivery system.The contrast between the coil and the catheter was found stretched at the place of the fracture.The physician tried to continue to use the device and cut off the stretched and broken part and tried to place the released coil, which was exposed outside of the delivery system, into the contrast catheter, but ultimately failed.The procedure was completed with a different device.No complications were reported, and the patient was stable.

• 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 T12 Y K88; EI T12 YK88
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 17793001
• MDR Text Key: 323975281
• Report Number: 2124215-2023-50927
• 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: 09/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/21/2023
• 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: 0031856845
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/08/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/20/2023
• 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: CORDIS5F
• Patient Age: 65 YR
• Patient Sex: Male
• Patient Weight: 65 KG