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

Model Number M001363610

Device Problem Uncoiled (1659)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/15/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Device evaluated by mfr: it is indicated that the device will not be returned for evaluation.A review of the batch history, historical trending, and similar complaint trending review for the product family will be conducted.If there is any further relevant information from that review, a supplemental mdr will be filed.(b)(4).

Event Description

It was reported that a coil protrusion occurred.A 10mm x 40cm interlock 35 was selected as the third and final coil to be deployed in a portal vein embolization.The anatomy was noted to be mildly tortuous; however, it was noted there was one tight loop immediately proximal to the embolization site.Using a.035 non bsc catheter, this coil was deployed without issue until the last few millimeters which straightened out and did not coil around the rest of the coil mass.This left a "tail" protruding into the vein.No further patient complications were reported and the patient's status 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: 5225896
• MDR Text Key: 31271751
• Report Number: 2134265-2015-07750
• Device Sequence Number: 1
• Product Code: KRD
• Combination Product (y/n): N
• Reporter Country Code: GB
• PMA/PMN Number: K110295
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/19/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M001363610
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/19/2015
• 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
• Treatment: .035 COOK CATHETER