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

Model Number	83787
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/11/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluated by manufacturer: the device was returned for analysis.A delivery wire, main coil and introducer sheath were returned for this complaint.Besides, a rhv was returned.The coil and delivery wire arms were not interlocked, the main coil was outside the introducer sheath.The introducer sheath was kinked in the twist lock section, the twist lock had been opened.The main coil was found stretched, besides, the fiber bundles had blood residues.Microscopic inspection of the delivery wire was performed and revealed that the proximal end has a smooth surface.The delivery wire was found kinked, near to the interlocking arm.The interlocking arm do not showed any damage.The interlocking arm was found detached from the coil.Microscopic inspection of main coil was performed and revealed that the zap tip has a smooth surface.The main coil was stretched.Dimensional inspection of the main coil and delivery wire that could be measured were performed and were within specifications.
Event or Problem Description
Reportable based on device analysis completed on 22aug2019.It was reported that the coil could not detach.The target lesion was located in the abdominal aorta.A 15mmx25cm interlock-35 was selected for use.During procedure, it was noted that the coil reached the lesion part in the vessel but could not detach.The procedure was completed with another of the same device.No complications reported and patient is stable.However, device analysis revealed that the interlocking arm 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: 9076214
• Report Number: 2134265-2019-11267
• Device Sequence Number: 11555713
• Product Code: KRD
• UDI-Device Identifier: 08714729793113
• UDI-Public: 08714729793113
• 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,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/17/2019

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: 06/05/2021
• Device Model Number: 83787
• Device Catalogue Number: 83787
• Device Lot Number: 0022212238
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/01/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/22/2019
• Initial Report FDA Received Date: 09/17/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 65 YR
• Patient Weight: 71