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

Model Number	83779
Medical Device Problem Codes	Difficult to Insert (1316); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/21/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluated by manufacturer: the device was returned for analysis.Visual inspection revealed that a pusher wire, coil and introducer sheath were returned for this complaint.The coil and pusher wire arms were interlocked within introducer sheath.The twist lock of the introducer sheath had been opened.Residues of blood were noted within the introducer sheath.The introducer sheath was inspected and no anomalies were noted.The pusher wire was inspected and was found kinked and detached.The coil was returned stretched and kinked near the interlocking arm.No more damages were found.Functional inspection revealed that the pusher 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 pusher wire showed that the pusher wire was detached, the detached section was not returned.The interlocking arm of the pusher wire was inspected and no anomalies were noted.The main coil zap tip has a smooth surface.The interlocking arm was inspected and was found damaged.Dimensional inspection of the pusher wire and main coil revealed that the components were within specification.
Event or Problem Description
Reportable based on device analysis completed on 28sep2019.It was reported that the resistance was felt during coil advancement.A 10mm x 30cm interlock coil was selected for use.During the procedure, it was noted that resistance was felt when advancing the coil to the middle of the micro catheter.Advancement was continued; however the micro catheter missed the lesion due to the large resistance.Then, the coil was withdrawn to the protect sheath and the coil was placed into heparin and the position of the micro catheter was adjusted through the micro guidewire.Another attempt was made to advance the coil; however, it could not be pushed.The coil was then placed in heparin and pulled forward and backward; however, the coil could only be pulled backward but it could not be pushed forward.Finally, physician tried to advance with strength but failed because the delivery shaft was kinked.The device was removed within the catheter all together from the patient's body.The procedure was completed with another of the same device.There were no complications and the patient's condition was stable post procedure.However, device analysis revealed that the pusher wire was detached.
Additional Manufacturer Narrative
Device evaluated by manufacturer: the device was returned for analysis.Visual inspection revealed that a pusher wire, coil and introducer sheath were returned for this complaint.The coil and pusher wire arms were interlocked within introducer sheath.The twist lock of the introducer sheath had been opened.Residues of blood were noted within the introducer sheath.The introducer sheath was inspected and no anomalies were noted.The pusher wire was inspected and was found kinked and detached.The coil was returned stretched and kinked near the interlocking arm.No more damages were found.Functional inspection revealed that the pusher 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 pusher wire showed that the pusher wire was detached, the detached section was not returned.The interlocking arm of the pusher wire was inspected and no anomalies were noted.The main coil zap tip has a smooth surface.The interlocking arm was inspected and was found damaged.Dimensional inspection of the pusher wire and main coil revealed that the components were within specification.
Event or Problem Description
Reportable based on device analysis completed on 28sep2019.It was reported that the resistance was felt during coil advancement.A 10mm x 30cm interlock coil was selected for use.During the procedure, it was noted that resistence was felt when advancing the coil to the middle of the micro catheter.Advancement was continued; however the micro catheter missed the lesion due to the large resistance.Then, the coil was withdrawn to the protect sheath and the coil was placed into heparin and the position of the micro catheter was adjusted through the micro guidewire.Another attempt was made to advance the coil; however, it could not be pushed.The coil was then placed in heparin and pulled forward and backward; however, the coil could only be pulled backward but it could not be pushed forward.Finally, physician tried to advance with strength but failed because the delivery shaft was kinked.The device was removed within the catheter all together from the patient's body.The procedure was completed with another of the same device.There were no complications and the patient's condition was stable post procedure.However, device analysis revealed that the pusher wire was detached.It was further reported that the pusher wire was detached during the procedure.

• 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: 9232929
• Report Number: 2134265-2019-12929
• Device Sequence Number: 18929333
• Product Code: KRD
• UDI-Device Identifier: 08714729765035
• UDI-Public: 08714729765035
• 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): 11/19/2019

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: 06/09/2021
• Device Model Number: 83779
• Device Catalogue Number: 83779
• Device Lot Number: 0022355359
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/10/2019
• Initial Date Received by Manufacturer: 09/28/2019
• Supplement Date Received by Manufacturer: 10/25/2019
• Initial Report FDA Received Date: 10/24/2019
• Supplement Report FDA Received Date: 11/19/2019
• 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: STC18; CATHETER: STC18
• Patient Age: 51 YR