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

Model Number	83787
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/23/2018
Type of Reportable Event	Malfunction
Event or Problem Description
Reportable based on device analysis completed on 29-aug-2018.It was reported that the coil became stuck in the catheter.The target lesion was located in the moderately tortuous and mildly calcified vessel.A 10mm/ 25cm interlock-35 was selected for use.During procedure, after bypass was completed, viahbahn was placed.Blood flowed in the brachiocephalic aneurysm, so coiling was started around the viahbahn and into the aneurysm.After placing 3 coils (20mm, 18mm and 15mm interlock), this 10mm coil was tried to place; however, the coil became stuck in the distal part of the 0.038 non-bsc catheter.The coil was then removed from the patient's body together with the catheter.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 from the rest of the coil and not returned.The device was returned for analysis.The unit returned has coil unraveled, as part of overall visual revision.Visual inspection was performed and observed that only a coil was returned.The coil interlocking arm was found detached from the rest of the coil, in addition it was not returned.Microscopic inspection of the main coil was performed and observed that the zap tip has a smooth surface.Dimensional inspection of the coil dimensions that could be measured 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: 7889943
• Report Number: 2134265-2018-61130
• Device Sequence Number: 16621461
• Product Code: KRD
• UDI-Device Identifier: 08714729793106
• UDI-Public: 08714729793106
• 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): 09/19/2018

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: 83787
• Device Catalogue Number: 83787
• Device Lot Number: 0020926956
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/07/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/29/2018
• Initial Report FDA Received Date: 09/19/2018
• 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- 0.038IN TEMPO