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

Model Number	83779
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/20/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluated by mfr: a visual inspection revealed that a coil and non-bsc catheter were returned for this complaint.The coil was stuck inside the non-bsc catheter.No more damages were found in the device.A functional and microscopic inspection revealed that the coil was stuck inside the non-bsc catheter and it was necessary to cut the sheath in order to release it; however, it exit from the catheter with a lot resistance.The coil was found damaged (stretched, kinked.The main coil zap tip and interlocking arm were found detached with missing number of fiber bundles.
Event or Problem Description
Reportable based on device analysis completed on 26may2020.It was reported that the coil could not be withdrawn from the catheter.A target lesion was located at the fundus of stomach.A 10mm x 50cm interlock coil was selected for use in gastric fundus for vein bleeding.During procedure, it was noted that the coil could not be pushed or withdrew when the microcatheter was advanced.However, it was further reported that continuous flushing was performed.Subsequently, the coil was removed with the catheter from the patient without any intervention.The bsc microcatheter used has no issue.The procedure was completed with another of the same device.No complications reported and patient was stable post procedure.However, device analysis revealed interlocking arm detached and missing fiber bundles.

• Brand Name: INTERLOCK
• Common Device Name: DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 10138660
• Report Number: 2134265-2020-07750
• Device Sequence Number: 1800643
• Product Code: KRD
• UDI-Device Identifier: 08714729845287
• UDI-Public: 08714729845287
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K132578
• 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
• Report Date (Section B): 06/10/2020

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: 07/15/2022
• Device Model Number: 83779
• Device Catalogue Number: 83779
• Device Lot Number: 0024270748
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/08/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/26/2020
• Initial Report FDA Received Date: 06/10/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 39 YR
• Patient Weight: 70