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

Model Number	83786
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/20/2018
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 05-sep-2018.It was reported that coil became stuck in the catheter.The target lesion was located in the mildly calcified internal iliac artery (iia).A 12mm /20cm interlock-35 was selected for use.During procedure, the coil was used in a 5fr non-bsc imaging catheter; however, the coil got stuck and could not be pushed and pulled in the mid part of the catheter.The coil was then removed together with the catheter from the patient's body.The procedure was completed with another of the same device.No patient complications were reported.However, device analysis revealed that coil interlocking arm was found detached from the rest of the coil and not returned.The device was returned for analysis.Visual inspection was performed on the delivery wire, coil and introducer sheath that were returned for this complaint.The coil and delivery 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 coil and delivery wire were advanced with friction from the introducer sheath caused by the blood observed.The introducer sheath and delivery wire were visually inspected and no anomalies were noted.The coil was visually inspected and kinked near the zap tip was noted.The coil interlocking arm was found detached from the rest of the coil, in addition, it was returned stretched near the interlocking arm end.Microscopic inspection was performed on the delivery wire and main coil, it was noted that the zap tip has a smooth surface.Dimensional inspection of the delivery wire and coil were performed and were within specifications.

• Brand Name: INTERLOCK-35
• Common Device Name: DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION
• Manufacturer (Section D): BOSTON SCIENTIFIC CORK LIMITED; cork business technology park; model farm road; cork ; EI
• MDR Report Key: 7901674
• Report Number: 2134265-2018-61232
• Device Sequence Number: 1395596
• Product Code: KRD
• UDI-Device Identifier: 08714729793175
• UDI-Public: 08714729793175
• 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): 09/24/2018

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: 07/24/2020
• Device Model Number: 83786
• Device Catalogue Number: 83786
• Device Lot Number: 0020926942
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/22/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/05/2018
• Initial Report FDA Received Date: 09/24/2018
• 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: IMAGING CATHETER- HIRATA 5FR