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

Model Number	83787
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/28/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Age at time of event: 18 years old or older.Device evaluated by manufacturer: the device was returned for analysis.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 the interlocking arm was detached and it was not returned.Besides, the main coil fiber bundles had blood residues on them.
Event or Problem Description
Reportable based on device analysis completed on 09-jan-2019.It was reported that coil got caught in the hub part of the catheter.A 15mm/25cm.035 interlock-35 was selected for embolization of the target lesion.During the procedure, the coil got caught in the hub part of the angiographic catheter and could not be inserted.The coil was simply removed from the patient.The procedure was completed with another of same device.No complications reported and patient's condition is good.However, device analysis revealed that the interlocking arm was detached from the coil.

• 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: 8276941
• Report Number: 2134265-2019-00358
• Device Sequence Number: 14042698
• 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): 01/25/2019

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: 05/31/2020
• Device Model Number: 83787
• Device Catalogue Number: 83787
• Device Lot Number: 0020715092
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/20/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/09/2019
• Initial Report FDA Received Date: 01/25/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1