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

Model Number	83787
Medical Device Problem Codes	Material Twisted/Bent (2981); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/19/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluated by manufacturer: the device was returned for analysis.Only the delivery wire was returned for this complaint.The main coil and introducer sheath were not returned, besides, a non bsc microcatheter was returned.The pusher wire was retuned inside the microcatheter.The delivery wire was inspected and was found kinked.The interlocking arm was inspected and was found kinked.No more damages were found in the returned device.The delivery wire was advanced through the introducer sheath, but it was not possible to continue advancing it due to was stuck; it was necessary to cut the microcatheter in order to release the delivery wire.The proximal end of the delivery wire has a smooth surface.The interlocking arm was found kinked.Dimensional inspection revealed that the weld and wire zap tip outer diameter were within specification; however the wire arm outer diameter (od) failed specification.
Event or Problem Description
Reportable based on device analysis completed on 12feb2020.It was reported that the coil pusher was bent.A 6mm x 10cm interlock coil was selected for use.During the procedure, when the coil was introduced into an angiodynamic bern catheter, the physician pushed the coil past the end of the catheter and the coil pusher made a 90 degree bend.The physician was unable to retract the coil pusher and had to pull everything out as a unit.The procedure was completed with another of the same device.There were no complications reported and patient condition was stable post procedure.However, device analysis revealed that the main coil was not returned.

• 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: 9771289
• Report Number: 2134265-2020-02335
• Device Sequence Number: 778810
• Product Code: KRD
• UDI-Device Identifier: 08714729793069
• UDI-Public: 08714729793069
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K133208
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/28/2020

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: 09/08/2022
• Device Model Number: 83787
• Device Catalogue Number: 83787
• Device Lot Number: 0024395905
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/14/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/12/2020
• Initial Report FDA Received Date: 02/28/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1