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

Model Number	83777
Medical Device Problem Codes	Break (1069); Entrapment of Device (1212); Stretched (1601)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/23/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the main coil was broken.A 2/5mm x 5.8cm vortx diamond interlock coil was selected for use.During a gastroesophageal varices embolization, after 8x20 and 6x10 coils were deployed, it was noted that the 5x5.8 coil was stuck and was broken.When the device was slowly pulled, it was further noted that the coil was stretched.The device was completely removed from the patient's body without any intervention and the procedure was completed with another of the same device.No patient complications were reported and patient was stable post procedure.
Event or Problem Description
It was reported that the main coil was broken.A 2/5mm x 5.8cm vortx diamond interlock coil was selected for use.During a gastroesophageal varices embolization, after 8x20 and 6x10 coils were deployed, it was noted that the 5x5.8 coil was stuck and was broken.When the device was slowly pulled, it was further noted that the coil was stretched.The device was completely removed from the patient's body without any intervention and the procedure was completed with another of the same device.No patient complications were reported and patient was stable post procedure.
Additional Manufacturer Narrative
Device evaluated by mfr: the device was returned for evaluation.The pusher wire and the main coil was returned inside the introducer sheath.They were interlock inside the introducer sheath.The introducer sheath was inspected and no damages was found.Main coil was kinked and stretched.The wire pusher was bent/kinked.No more damages were found in the device.The coil and pusher wire were release from the introducer sheath without any resistance.The proximal end has a smooth surface.The interlocking arm was inspected and no anomalies was noted.The zap tip has a smooth surface.The interlocking arm was inspected and no anomalies was noted.Dimensional inspection of the pusher wire and main coil revealed the components were within specification except the number of fiber bundles, which were only 20 out of 25.

• 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: 9938143
• Report Number: 2134265-2020-04601
• Device Sequence Number: 10923551
• Product Code: KRD
• UDI-Device Identifier: 08714729765103
• UDI-Public: 08714729765103
• 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,Followup
• Report Date (Section B): 05/28/2020

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: 04/08/2022
• Device Model Number: 83777
• Device Catalogue Number: 83777
• Device Lot Number: 0023763397
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/05/2020
• Initial Date Received by Manufacturer: 03/23/2020
• Supplement Date Received by Manufacturer: 05/25/2020
• Initial Report FDA Received Date: 04/08/2020
• Supplement Report FDA Received Date: 05/28/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 51 YR
• Patient Weight: 72