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

Model Number 83786

Device Problems Premature Activation (1484); Stretched (1601); Detachment of Device or Device Component (2907); Positioning Problem (3009); Physical Resistance/Sticking (4012)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/20/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(6).

Event Description

It was reported the coil protruded from the catheter tip.The target lesion area was located in a mildly tortuous inferior mesentery artery (ima).A 4mmx10cm interlock 0.35 embolic coil was selected for use in an endovascular aneurysm repair.Ima was accessed using a non-bsc angiographic catheter.Embolization was started with the interlock35 and was successful until midway of the second device where a kink on the non-bsc angiographic catheter was observed.The delivery was started, and when the coil came out about 5 cm from the tip of the catheter, kink was significantly observed than before along with a kickback of the catheter.However, the interlocking arm part became caught in the kink.Although the distal part of the coil was placed into ima, early detachment occurred as it was pushed.It was attempted to push the coil with a non-bsc guidewire to come it out of the catheter, but the coil was unraveled in the middle of the catheter and the unraveled coil was protruded from the tip of the catheter into the aorta.Coil usage was stopped as the graft was placed.Subsequently, fragment like thin wire was observed.The coil on the proximal side was still in the catheter, the catheter was pulled to remove the coil.The coil also came to the sheath valve part, so it was slowly pulled out and the retrieval was completed.No patient complications reported.

Manufacturer Narrative

E1.Initial reporter facility name: (b)(6) hospital.E1.Initial reporter city: (b)(6).Device evaluated by manufacturer: the delivery wire, main coil and introducer sheath were not returned.Only a cordis 4frtempo was returned.No issues were noted.

Event Description

It was reported the coil protruded from the catheter tip.The target lesion area was located in a mildly tortuous inferior mesentery artery (ima).A 4mmx10cm interlock 0.35 embolic coil was selected for use in an endovascular aneurysm repair.Ima was accessed using a non-bsc angiographic catheter.Embolization was started with the interlock35 and was successful until midway of the second device where a kink on the non-bsc angiographic catheter was observed.The delivery was started, and when the coil came out about 5 cm from the tip of the catheter, kink was significantly observed than before along with a kickback of the catheter.However, the interlocking arm part became caught in the kink.Although the distal part of the coil was placed into ima, early detachment occurred as it was pushed.It was attempted to push the coil with a non-bsc guidewire to come it out of the catheter, but the coil was unraveled in the middle of the catheter and the unraveled coil was protruded from the tip of the catheter into the aorta.Coil usage was stopped as the graft was placed.Subsequently, fragment like thin wire was observed.The coil on the proximal side was still in the catheter, the catheter was pulled to remove the coil.The coil also came to the sheath valve part, so it was slowly pulled out and the retrieval was completed.No patient complications reported.

• 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: 10510461
• MDR Text Key: 206546004
• Report Number: 2134265-2020-12562
• Device Sequence Number: 1
• Product Code: KRD
• UDI-Device Identifier: 08714729792987
• UDI-Public: 08714729792987
• 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: 10/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/09/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/04/2023
• Device Model Number: 83786
• Device Catalogue Number: 83786
• Device Lot Number: 0025303865
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/01/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CORDIS 4FR TEMPO CATHETER; CORDIS 4FR TEMPO CATHETER; INTRODUCER SHEATH-16FR CENTRANT (MEDTRONIC); INTRODUCER SHEATH-16FR CENTRANT (MEDTRONIC)