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

Model Number	83787
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/22/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the device was broken.A 8mm/20cm 0.35 interlock-35 was selected for embolization of the renal arterial aneurysm.During the procedure, the pusher wire arm was found to be broken inside the catheter.The device was removed within the catheter all together and it was confirmed that there was no fragments of the device that was left inside the patient.The procedure was completed with another of same device.No patient complications reported and patient is stable.
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.The coil and delivery wire arms were interlocked, the main coil returned inside the introducer sheath.The introducer sheath was inspected and no anomalies were noted, the twist lock had been opened.The main coil was found kinked and stretched, besides, the zap tip was detached and it was not returned.The delivery wire was in good condition, it did not show damages.Functional inspection was performed and revealed that the delivery wire was advanced through the introducer sheath and no resistance was felt; the main coil was delivered without any problem.Microscopic inspection of the delivery wire was performed and revealed that the proximal end has a smooth surface.The interlocking arm was in good condition.Dimensional inspection of the delivery wire and main coil were performed and were within specifications.
Event or Problem Description
It was reported that the device was broken.A 8mm/20cm 0.35 interlock-35 was selected for embolization of the renal arterial aneurysm.During the procedure, the pusher wire arm was found to be broken inside the catheter.The device was removed within the catheter all together and it was confirmed that there was no fragments of the device that was left inside the patient.The procedure was completed with another of same device.No patient complications reported and patient is stable.

• 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: 8273704
• Report Number: 2134265-2019-00321
• Device Sequence Number: 168180
• 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,Followup
• Report Date (Section B): 02/27/2019

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: 01/15/2021
• Device Model Number: 83787
• Device Catalogue Number: 83787
• Device Lot Number: 0021615385
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/25/2019
• Initial Date Received by Manufacturer: 01/04/2019
• Supplement Date Received by Manufacturer: 02/07/2019
• Initial Report FDA Received Date: 01/24/2019
• Supplement Report FDA Received Date: 02/27/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 58 YR
• Patient Weight: 60