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

Model Number M001363630

Device Problem Fracture (1260)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/13/2016

Event Type  malfunction  

Manufacturer Narrative

Age at time of event: 18 years or older.(b)(4).

Event Description

It was reported that coil fracture occurred.The target lesion was located in the iliac artery.A 12mmx40cm interlock⭳5 was selected for use.During the procedure after the coil was deployed, it was noted that the coil detached from the interlocking arm.The catheter was pulled and removed together with the fractured coil out of the patient's body without difficulties.The procedure was completed with another of the same device.No patient complications were reported and the patient's condition was stable.

Manufacturer Narrative

Device evaluated by manufacturer: the introducer sheath and coil were returned for analysis.The coil was returned outside the introducer sheath.The introducer sheath was inspected and blood was present.The twist lock had been opened.The coil was inspected and found to be severely stretched and kinked in the middle.The zap tip shape and surface of the coil was smooth.The interlocking arm of the coil was inspected and the arm was kinked.The delivery wire dimensions were found to be in specification.The coil dimensions that could be measured were found to be in specification.The number of proximal fiber bundles recorded during product analysis was below the assigned specification.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The most probable root cause has been determined to be use/user error as insufficient flush was used during the procedure.The dfu states that ¿in order to achieve optimal performance of the interlock - 35 fibered idc occlusion system and reduce the risk of thromboembolic complications, it is critical that the 5f imager ii selective diagnostic catheter is flushed vigorously, either utilizing a continuous flush or hand injection setup, before and after the introduction of each interlock - 35 fibered idc occlusion system.¿ (b)(4).

Event Description

It was reported that coil fracture occurred.The target lesion was located in the iliac artery.A 12mmx40cm interlock¿ -35 was selected for use.During the procedure after the coil was deployed, it was noted that the coil detached from the interlocking arm.The catheter was pulled and removed together with the fractured coil out of the patient's body without difficulties.The procedure was completed with another of the same device.No patient complications were reported and the patient's condition was stable.

• Brand Name: INTERLOCK¿-35
• Type of Device: DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION
• Manufacturer (Section D): BOSTON SCIENTIFIC - CORK; business and technology park; model farm road; cork ; EI
• Manufacturer (Section G): BOSTON SCIENTIFIC - CORK; business and technology park; model farm road; cork ; EI
• Manufacturer Contact: linda leimer ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 5646313
• MDR Text Key: 45006061
• Report Number: 2134265-2016-04137
• Device Sequence Number: 1
• Product Code: KRD
• Combination Product (y/n): N
• Reporter Country Code: CN
• PMA/PMN Number: K110295
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/15/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/11/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2018
• Device Model Number: M001363630
• Device Catalogue Number: 36-363
• Device Lot Number: 18399061
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/21/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/12/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/05/2015
• 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