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

Model Number	83786
Medical Device Problem Codes	Material Protrusion/Extrusion (2979); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	Vascular Dissection (3160)
Date of Event	08/06/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that vessel dissection and coil protrusion occurred.The target lesion was located in the venue spermatica.A 10mmx 20cm interlock-35 was selected for use.During procedure, it was noted that the coil became stuck in a non-bsc catheter and it was unknown whether it was flushed sufficiently; they did flush.Both coil and catheter were then removed at once from the sheath out of the patient.However, the coil was protruding at the catheter's tip upon removal and a dissection of the vena occurred.There was no need to repair since the hemostasis of the blood caused blood clotting, because of which a natural emboli occurred; that is the reason they did not used additional products to finish the procedure.No further patient complications were reported.
Event or Problem Description
It was reported that vessel dissection and coil protrusion occurred.The target lesion was located in the venue spermatica.A 10mmx 20cm interlock-35 was selected for use.During procedure, it was noted that the coil became stuck in a non-bsc catheter and it was unknown whether it was flushed sufficiently; they did flush.Both coil and catheter were then removed at once from the sheath out of the patient.However, the coil was protruding at the catheter's tip upon removal and a dissection of the vena occurred.There was no need to repair since the hemostasis of the blood caused blood clotting, because of which a natural emboli occurred; that is the reason they did not used additional products to finish the procedure.No further patient complications were reported.The device was returned for analysis.The coil is stuck inside of a non bsc catheter, as part of overall visual revision.A delivery wire, main coil and introducer sheath were returned for this complaint.The main coil returned inside of a non-bsc device (cook 5 fr).The coil and delivery wire arms were not interlocked due to the delivery wire and the coil returned outside the introducer sheath.The introducer sheath was inspected and no anomalies were noted; the twist lock had been opened.The fiber bundles of the coil had blood residues.The delivery wire had the interlocking arm kinked.The main coil had the interlocking arm detached.The main coil was stuck inside the non-bsc catheter and it was necessary to cut the catheter in order to release the coil.Microscopic inspection of the delivery wire was performed and revealed that the proximal end has a smooth surface.The interlocking arm was found kinked.Microscopic inspection of the main coil was performed and revealed that the main coil was stretched and kinked and the interlocking arm was detached; more stretched sections were observed along the main coil.The coil dimensions that could be measured were inspected and were within specifications.

• Brand Name: INTERLOCK-35
• Common Device Name: DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; model farm road; maple grove MN 55311
• MDR Report Key: 7845693
• Report Number: 2134265-2018-60785
• Device Sequence Number: 13732333
• Product Code: KRD
• UDI-Device Identifier: 08714729793137
• UDI-Public: 08714729793137
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K133208
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/22/2018

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
• Operator of Device: Health Professional
• Device Expiration Date: 01/03/2021
• Device Model Number: 83786
• Device Catalogue Number: 83786
• Device Lot Number: 0021568204
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/08/2018
• Initial Date Received by Manufacturer: 08/09/2018
• Supplement Date Received by Manufacturer: 09/28/2018
• Initial Report FDA Received Date: 09/05/2018
• Supplement Report FDA Received Date: 10/22/2018
• 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: CATHETER- COOK; CATHETER- COOK; CATHETER- COOK
• Outcome Attributed to Adverse Event: Other