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

Model Number	83786
Medical Device Problem Codes	Premature Activation (1484); Stretched (1601); Detachment of Device or Device Component (2907); Positioning Problem (3009); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/20/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).
Event or Problem 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.
Additional 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 or Problem 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
• Common Device Name: DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 10510461
• Report Number: 2134265-2020-12562
• Device Sequence Number: 11639842
• Product Code: KRD
• UDI-Device Identifier: 08714729792987
• UDI-Public: 08714729792987
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K133208
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: 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
• Initial Date Received by Manufacturer: 08/20/2020
• Supplement Date Received by Manufacturer: 10/01/2020
• Initial Report FDA Received Date: 09/09/2020
• Supplement Report FDA Received Date: 10/02/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CORDIS 4FR TEMPO CATHETER; CORDIS 4FR TEMPO CATHETER; INTRODUCER SHEATH-16FR CENTRANT (MEDTRONIC); INTRODUCER SHEATH-16FR CENTRANT (MEDTRONIC)