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

Model Number	83786
Medical Device Problem Codes	Entrapment of Device (1212); Separation Failure (2547)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/23/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the coil protruded in the catheter's tip during removal.A 18mmx40cm interlock-35 coil was selected for use on the abdominal aorta.During the procedure, after the coated stent was used, leakage was found and it was embolized with a coil.Then, this coil was deployed 2cm and was found to be in a bad position, so it was retrieved into the catheter and re-deployed.However, it was noted that the coil was stuck and could not be deployed inside the catheter distal part, and protruded in the catheter's tip during removal.The procedure was completed with another of the same device.No complications were reported and the patient was stable post procedure.
Additional Manufacturer Narrative
Device evaluated by mfr: the device was returned for analysis.A delivery wire, main coil and introducer sheath were returned for this complaint.The coil and delivery wire arms were interlocked within the introducer sheath.The introducer sheath was inspected and no anomalies was noted, the twist lock had been opened.The main coil was found kinked and stretched.No more damages were found in the returned device.The delivery wire was inspected and no anomalies were noted.Functional inspection was performed and the delivery wire was advanced through the introducer sheath, but it was not possible to continue advancing it due to the main coil was stuck; it was necessary to cut the sheath in order to release the main coil.Microscopic inspection of the delivery wire was performed and revealed that the proximal end has a smooth surface.The interlocking arm was inspected and not damages was found.Microscopic inspection of the main coil was performed and revealed that the zap tip has a smooth surface.The interlocking arm was inspected and no anomalies was noted.Dimensional inspection of the delivery wire weld outer diameter (od), wire arm od, and wire zap tip were performed and were within specifications.Dimensional inspection of the main coil no.Of distal fiber bundles, no.Of proximal fiber bundles, zap tip od, and primary coil od were performed and were within specifications.No other issues were identified during the product analysis.
Event or Problem Description
It was reported that the coil protruded in the catheter's tip during removal.A 18mmx40cm interlock-35 coil was selected for use on the abdominal aorta.During the procedure, after the coated stent was used, leakage was found and it was embolized with a coil.Then, this coil was deployed 2cm and was found to be in a bad position, so it was retrieved into the catheter and re-deployed.However, it was noted that the coil was stuck and could not be deployed inside the catheter distal part, and protruded in the catheter's tip during removal.The procedure was completed with another of the same device.No complications were reported and the patient was stable post procedure.

• 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: 10706001
• Report Number: 2134265-2020-14417
• Device Sequence Number: 3483562
• Product Code: KRD
• UDI-Device Identifier: 08714729795414
• UDI-Public: 08714729795414
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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): 12/14/2020

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: 02/25/2023
• Device Model Number: 83786
• Device Catalogue Number: 83786
• Device Lot Number: 0025269716
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/19/2020
• Initial Date Received by Manufacturer: 10/09/2020
• Supplement Date Received by Manufacturer: 12/03/2020
• Initial Report FDA Received Date: 10/20/2020
• Supplement Report FDA Received Date: 12/14/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 63 YR
• Patient Weight: 68