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

Model Number	83786
Medical Device Problem Codes	Separation Failure (2547); 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	04/24/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluated by mfr: the device was returned for analysis.Visual inspection revealed that a delivery wire, coil and introducer sheath were returned for this complaint.The coil and delivery wire arms were not interlocked, due to the interlocking arm of the coil was detached and it was not returned.The twist lock of the introducer sheath had been opened, kinked and stretched.Residues of blood were noted within the introducer sheath.The delivery wire was inspected and no anomalies were noted.The coil was inspected and was found kinked and stretched near the interlocking arm and zap tip.The interlocking arm of the coil was detached and it was not returned.A microscopic inspection revealed that the zap tip has a smooth surface, interlocking arm of the coil was detached and it was not returned,and main coil was found kinked and stretched near the zap tip and interlocking arm.Many of the fiber bundles of the delivery wire were detached.A dimensional inspection revealed that the weld outer diamter (od), weld arm od (max), and wire zap tip (max) of the delivery wire were within its specification.The zap tip od and primary coil od were within its specification.The no.Of distal fiber bundlesa and no.Of distal fiber bundles were unspecified.
Event or Problem Description
Reportable based on device analysis completed on 14jun2019.It was reported that the device was unable to deploy.A 12mm x 20cm interlock-35 was selected for use.During preparation, it was noted that the coild was unable to deploy and could not pushed through.The procedure was completed with another of the same.There were no patient complications reported.Patient is stable.However, device analysis revealed that many of the fiber bundles were 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: 8732984
• Report Number: 2134265-2019-07432
• Device Sequence Number: 2271656
• Product Code: KRD
• UDI-Device Identifier: 08714729793175
• UDI-Public: 08714729793175
• 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): 06/25/2019

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: 09/20/2021
• Device Model Number: 83786
• Device Catalogue Number: 83786
• Device Lot Number: 0022686062
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/30/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/14/2019
• Initial Report FDA Received Date: 06/25/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 72 YR
• Patient Weight: 54