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

Model Number	83779
Medical Device Problem Codes	Stretched (1601); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/16/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Age at time of event: 18 years or older.
Event or Problem Description
Reportable based on device analysis completed on 13-nov-2018.It was reported that the coil did not coil up and became elongated.The target lesion was located in severely tortuous splenorenal vein.During the procedure, the device was used with a non- bsc catheter.However, it was noted that the coil did not coil up successfully and got elongated when it was pulled and pushed.The device was then simply pulled out from the patient.The procedure was completed with another of the same device.No patient complications were reported.However, device analysis revealed that the interlocking arm of the coil was detached and not returned; there were missing coil fiber bundles.Device evaluated by manufacturer: the device was returned for analysis.A coil was returned for this complaint.The pusher wire and the introducer sheath were not returned.The coil was returned stretched, kinked and the interlocking arm was detached and it was not returned.Microscopic inspection of the main coil revealed that the zap tip has a smooth surface.The coil was stretched and kinked.Dimensional inspection of the coil was performed and revealed that the outer diameter (od) of the zap tip and od of primary coil were within specifications.The coil fiber bundles are lacking 13.

• 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: 8146583
• Report Number: 2134265-2018-63767
• Device Sequence Number: 2266361
• Product Code: KRD
• UDI-Device Identifier: 08714729845294
• UDI-Public: 08714729845294
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 12/10/2018

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: 10/02/2020
• Device Model Number: 83779
• Device Catalogue Number: 83779
• Device Lot Number: 0021330574
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/02/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/13/2018
• Initial Report FDA Received Date: 12/10/2018
• 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- 0.025 INCH HIRATA LANTERN; GUIDE CATHETER: MEDIKIT 6F AL1; GUIDEWIRE: ASAHI MESTER; INTRODUCER SHEATH: CORDIS 6F