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

Model Number 83779

Device Problems Break (1069); Entrapment of Device (1212); Premature Activation (1484); Detachment of Device or Device Component (2907)

Patient Problems No Consequences Or Impact To Patient (2199); Device Embedded In Tissue or Plaque (3165)

Event Date 01/28/2020

Event Type  Injury  

Manufacturer Narrative

Weight: (b)(6) kgs.Initial reporter city: (b)(6).

Event Description

It was reported that the coil separated from the middle part and remained inside patient.The target lesion was located in the bronchial artery.A 2mmx4cm interlock was selected for use.During the procedure, it as noted that the coil became stuck on the tip part of a non-bsc catheter and was removed.However, the coil separated at the middle part and was left inside patient from bronchial artery to aorta.The proximal side was removed protruding from the catheter's tip.There was no resistance upon retrieving the catheter and the coil and no possibility of adhesion of thrombus.No complications reported and the patient is stable.

Manufacturer Narrative

A4.Weight- 67.5 kgs.E1.Initial reporter city: (b)(6).Initially reported h6 patient code description as device fragments in patient 3165 and device code description entrapment of device 1212.Corrected codes to no consequence or impact to patient 2199 and device code premature activation 1484.

Event Description

It was reported that the coil separated from the middle part and remained inside patient.The target lesion was located in the bronchial artery.A 2mmx4cm interlock was selected for use.During the procedure, it as noted that the coil became stuck on the tip part of a non-bsc catheter and was removed.However, the coil separated at the middle part and was left inside patient from bronchial artery to aorta.The proximal side was removed protruding from the catheter's tip.There was no resistance upon retrieving the catheter and the coil and no possibility of adhesion of thrombus.No complications reported and the patient is stable.It was further reported that the first coil that broke and detached within the patient was a 8cmx3mm interlock and the second coil was the 2mmx4cm interlock which prematurely deployed within the catheter and possibly tore within the catheter during removal.

Event Description

It was reported that the coil separated from the middle part and remained inside patient.The target lesion was located in the bronchial artery.A 2mmx4cm interlock was selected for use.During the procedure, it as noted that the coil became stuck on the tip part of a non-bsc catheter and was removed.However, the coil separated at the middle part and was left inside patient from bronchial artery to aorta.The proximal side was removed protruding from the catheter's tip.There was no resistance upon retrieving the catheter and the coil and no possibility of adhesion of thrombus.No complications reported and the patient is stable.It was further reported that the first coil that broke and detached within the patient was a 8cmx3mm interlock and the second coil was the 2mmx4cm interlock which prematurely deployed within the catheter and possibly tore within the catheter during removal.

Manufacturer Narrative

A4.Weight- 67.5 kgs.E1.Initial reporter city: (b)(6).Device evaluated by manufacturer: the device was returned for analysis.A pusher wire and coil were returned for this complaint.The coil and pusher wire arms were not interlocked.The pusher wire was inspected and no issues was noted.The coil was inspected and it was noted kinked.No more damages were found in the returned device.Microscopic inspection of the pusher wire was performed and observed that the zap tip has a smooth surface.The interlocking arm was inspected and no anomalies were noted.Microscopic inspection of the main coil was performed and observed that the zap tip has a smooth surface.The interlocking arm was inspected and no anomalies were noted.Dimensional inspection of the pusher wire and main coil that could be measured were performed and were within specifications.

• Brand Name: INTERLOCK
• Type of Device: DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 9721896
• MDR Text Key: 180218116
• Report Number: 2134265-2020-01651
• Device Sequence Number: 1
• Product Code: KRD
• UDI-Device Identifier: 08714729845263
• UDI-Public: 08714729845263
• Combination Product (y/n): N
• PMA/PMN Number: K132578
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup,Followup
• Report Date: 04/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/12/2022
• Device Model Number: 83779
• Device Catalogue Number: 83779
• Device Lot Number: 0023492689
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/20/2020
• Initial Date Manufacturer Received: 01/28/2020
• Initial Date FDA Received: 02/18/2020
• Supplement Dates Manufacturer Received: 02/17/2020; 03/18/2020
• Supplement Dates FDA Received: 03/03/2020; 04/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CATHETER- BREAKTHROUGH 2 MARKER.; CATHETER- BREAKTHROUGH 2 MARKER.; CATHETER- BREAKTHROUGH 2 MARKER.; COIL- INTERLOCK 18 (8CMX3MM).; COIL- INTERLOCK 18 (8CMX3MM).; COIL- INTERLOCK 18 (8CMX3MM).
• Patient Outcome(s): Other
• Patient Age: 54 YR