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

Model Number M001361760

Device Problems Fracture (1260); Difficult to Insert (1316)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/04/2014

Event Type  Injury  

Event Description

It was reported that the coil became fractured.A moderately tortuous target lesion was located at superior mesenteric artery.During the procedure, a.021 renegade catheter was used and 4 coils were deployed.A 2/5mm x 5.8cm interlock coil was selected as the 5th coil to treat the target lesion.Upon deployment of the 5th coil, resistance was encountered prior to removing the plastic sheath.The physician tried to withdraw the coil, but it was noted that the coil fractured at the arrow point of the radiopaque marker.The patient went for surgery.No further patient complications were reported.Patient status was fine after surgery.

Manufacturer Narrative

Age at time of event: 18 years or older.(b)(4).Device evaluated by manufacturer.The device was not returned for analysis therefore the as reported defect could not be confirmed.The batch number is unknown and the manufacturing records for the complaint device could not be reviewed.The most probable root cause has been determined to be use/user error as the dfu states ¿in order to achieve excellent performance of the interlock fibered idc occlusion system and reduce the risk of thromboembolic complications, it is critical that a continuous flow of appropriate flush solution be maintained between the microcatheter and guiding catheter, and the microcatheter and any intraluminal device.Continuous flushing reduces retrograde blood flow into the microcatheter and introducer sheath during coil delivery, it also reduces contrast crystal formation and/or thrombosis on the delivery wire and in the guiding catheter and microcatheter lumens and reduces premature coil thrombosis." (b)(4).

Manufacturer Narrative

(b)(4).

Event Description

(b)(4).A 2mmx5mm interlock vertex retrievable coil was used to occlude the pseudoaneurysm.The physician inserted the coil and was not pleased with the coil position.He decided not to deploy the coil and pulled it out.He viewed under the fluoroscope and the coil become detached and left in an undesirable location.He tried to retrieve the coil via three different snare devices but unsuccessful and the patient went to surgery.

• Brand Name: INTERLOCK?
• 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: ingrid matte ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 3726074
• MDR Text Key: 21175222
• Report Number: 2134265-2014-01585
• Device Sequence Number: 1
• Product Code: KRD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K060078
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/06/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/03/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M001361760
• Device Catalogue Number: 36-176
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/15/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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 Outcome(s): Required Intervention