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

Model Number	83787
Medical Device Problem Code	Premature Activation (1484)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/11/2018
Type of Reportable Event	Malfunction
Event or Problem Description
Reportable based on device analysis completed on 08-nov-2018.It was reported that the coil detached in the catheter.Vascular access was obtain via contralateral approach.The target lesion was located in the moderately tortuous internal iliac artery.A 15mmx 25cm interlock-35 was selected for use.During procedure, the coil was advanced through a non- bsc catheter after placing several interlock coils.However, it was noted that the coil got early detached inside the catheter as the interlocking arm of the coil detached from the interlocking arm of the pusher wire.The procedure was completed with another of the same device.No patient complications were reported.However, device analysis revealed that the coil interlocking arm was detached and not returned.The device was returned for analysis.Only a main coil was returned for this complaint.The delivery wire and introducer sheath were not returned.The main coil was found kinked and stretched and dry blood residues were found in the coil fiber bundles; besides, the interlocking arm was detached from the coil.No more damages were found in the device.Microscopic inspection of the main coil was performed and observed that the zap tip has a smooth surface.The main coil was stretched and kinked near the interlocking arm; besides, the interlocking arm was detached and it was not returned.Dimensional inspection of the main coil was performed and were within specifications.

• 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: 8133322
• Report Number: 2134265-2018-63551
• Device Sequence Number: 141330
• Product Code: KRD
• UDI-Device Identifier: 08714729793113
• UDI-Public: 08714729793113
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K133208
• 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): 12/05/2018

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: 12/11/2020
• Device Model Number: 83787
• Device Catalogue Number: 83787
• Device Lot Number: 0021501125
• 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: 11/08/2018
• Initial Report FDA Received Date: 12/05/2018
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CATHETER- TEMPO