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); Separation Failure (2547)

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

Event Date 09/18/2023

Event Type  malfunction  

Event Description

It was reported that the interlocking arm was fractured.The 7.8mm, moderately tortuous target lesion was located in the splenic artery.A 10mm x 40cm.035 interlock coil was selected for use.During the procedure, after hepatic artery embolization, the device was advanced to splenic artery.It was noted that due to high blood flow, the coil could not be anchored.After repeated attempts, it could neither be pushed nor pulled back.After the entire non boston scientific imaging catheter and interlock were removed, it was found that the coil had been stretched and the interlocking arms were fractured.The procedure was completed with a different coil size.There were no patient complications reported and the patient status was stable post procedure.

Event Description

It was reported that the interlocking arm was fractured.The 7.8mm, moderately tortuous target lesion was located in the splenic artery.A 10mm x 40cm.035 interlock coil was selected for use.During the procedure, after hepatic artery embolization, the device was advanced to splenic artery.It was noted that due to high blood flow, the coil could not be anchored.After repeated attempts, it could neither be pushed nor pulled back.After the entire non boston scientific imaging catheter and interlock were removed, it was found that the coil had been stretched and the interlocking arms were fractured.The procedure was completed with a different coil size.There were no patient complications reported and the patient status was stable post procedure.

Manufacturer Narrative

Device evaluated by mfr.: the device was returned for analysis.The main coil, the pusher wire, and the introducer sheath were returned for the analysis.It was observed the main coil was stretched, detached, and bent at the coil arm section.Functional testing could not be performed due to the main coil and the pusher wire not interlocking.Dimensional inspection revealed that the zap tip and primary coil outer diameters were within specification.

• 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: 17931877
• MDR Text Key: 325863741
• Report Number: 2124215-2023-51877
• Device Sequence Number: 1
• Product Code: KRD
• UDI-Device Identifier: 08714729795513
• UDI-Public: 08714729795513
• 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,Followup
• Report Date: 12/13/2023

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: 83787
• Device Catalogue Number: 83787
• Device Lot Number: 0031626173
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/19/2023
• Initial Date FDA Received: 10/13/2023
• Supplement Dates Manufacturer Received: 11/20/2023
• Supplement Dates FDA Received: 12/13/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/16/2023
• 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: 48 YR
• Patient Sex: Male
• Patient Weight: 48 KG