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

Model Number	83787
Medical Device Problem Codes	Entrapment of Device (1212); Difficult to Insert (1316)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/06/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluated by mfr: the device was returned for evaluation.A delivery wire, main coil and introducer sheath were returned for this complaint.The coil and delivery wire arms were not interlocked.The introducer sheath was inspected and was found kinked near to distal tip, the twist lock had been opened.The main coil was found kinked and stretched near to interlocking arm.The interlocking arm was detached.The delivery wire was advanced through the introducer sheath, but it was not possible to continue advancing it as the main coil was stuck.It was necessary to cut the sheath in order to release the main coil.Microscopic inspection found the proximal end has a smooth surface.The interlocking arm was found kinked.The zap tip has a smooth surface.The main coil was found kinked and stretched near to interlocking arm.The interlocking arm was detached.Dimensional inspection revealed that the device is within specification.
Event or Problem Description
Reportable based on device analysis completed on 19nov2019.It was reported that the coil was stuck inside the catheter.An 8mm x 20cm interlock-35 was selected for use.During preparation, it was noted that the coil only reached the distal part of the catheter and could not advance to the proper position.Consequently, the coil was pulled back into the catheter.During the second attempt to advance the coil, the coil became stuck inside the catheter.The coil was removed within the catheter all together and the procedure was completed with another of the same device.No patient complications were reported and the patient was stable post procedure.However, device analysis revealed that the interlocking arm was detached.

• 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: 9395205
• Report Number: 2134265-2019-14585
• Device Sequence Number: 2132975
• Product Code: KRD
• UDI-Device Identifier: 08714729793052
• UDI-Public: 08714729793052
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K133208
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/02/2019

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: 08/06/2021
• Device Model Number: 83787
• Device Catalogue Number: 83787
• Device Lot Number: 0022477005
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/28/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/19/2019
• Initial Report FDA Received Date: 12/02/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 46 YR
• Patient Weight: 70