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

Model Number 83786

Device Problems Device Damaged by Another Device (2915); Device-Device Incompatibility (2919); Material Protrusion/Extrusion (2979)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/16/2019

Event Type  malfunction  

Manufacturer Narrative

Age at time of event: 18 years or older.(b)(6).

Event Description

It was reported that the device pierced the catheter and entered the patient.The target lesion was located in the hepatic vein.A 8mm x 20cm interlock-35 was selected for use.During the procedure, the device was advanced through a 4f non-bsc angiographic catheter.The interlock device pierced the outside of the catheter with the pusher.About 45-55mm of the coil had been advanced into the patient when the physician noted this.The coil was not deployed/detached from the pusher/delivery wire.The coil was able to be pulled out of the body, into the catheter, and removed from the patient.At this point, it seemed like enough coils had been implanted and intervention was stopped.No patient complications were reported and the patient is stable.

Manufacturer Narrative

Age at time of event: 18 years or older.Initial reporter phone: (b)(6).Device evaluated by manufacturer: the device was return for analysis.A rotating hemostatic valve (rhv), a stopcock, a delivery wire, an introducer sheath a coil and a non bsc catheter were returned for this complaint.The proximal section of the coil was returned exiting thru a hole in the catheter near the distal end of it.The distal section of the coil was returned protruding from the distal tip of the catheter.The delivery wire was inspected and no anomalies were noted.The coil was returned stretched near the interlocking arm.Residues of blood were noted within the rotating hemostatic valve (rhv).The interlocking arm was inspected and no anomalies was noted.The interlocking arm was inspected and no anomalies were noted.

Event Description

It was reported that the device pierced the catheter and entered the patient.The target lesion was located in the hepatic vein.A 8mm x 20cm interlock-35 was selected for use.During the procedure, the device was advanced through a 4f non-bsc angiographic catheter.The interlock device pierced the outside of the catheter with the pusher.About 45-55mm of the coil had been advanced into the patient when the physician noted this.The coil was not deployed/detached from the pusher/delivery wire.The coil was able to be pulled out of the body, into the catheter, and removed from the patient.At this point, it seemed like enough coils had been implanted and intervention was stopped.No patient complications were reported and the patient is stable.

• Brand Name: INTERLOCK-35
• Type of Device: DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 8509040
• MDR Text Key: 141759570
• Report Number: 2134265-2019-03803
• Device Sequence Number: 1
• Product Code: KRD
• UDI-Device Identifier: 08714729793045
• UDI-Public: 08714729793045
• Combination Product (y/n): N
• PMA/PMN Number: K133208
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 05/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/12/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/06/2021
• Device Model Number: 83786
• Device Catalogue Number: 83786
• Device Lot Number: 0022905401
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/11/2019
• Date Manufacturer Received: 05/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1