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

Model Number	83779
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/05/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the package was contaminated.A 14mmx50cm interlock coil was selected for use on the liver.During preparation, it was noted that the package was contaminated.Both the package seal and the sterility of the device were compromised.The device did not enter the patient's body and the procedure was completed with a different device.No complications were reported and the patient was stable post procedure.
Additional Manufacturer Narrative
Device evaluated by mfr: the device was returned for analysis.Device returned with its original opened packaging.The closure strip was present and it was opened.Some damages (crease/bend) were identified on the outer packaging.The original pouch was not received.The coil and a non-boston scientific catheter were returned for this complaint.The coil was found exiting the non-boston scientific catheter.The coil was inspected and it was kinked and stretched.The zap tip was detached and it was not returned.No damages were found.Functional inspection was performed and it was possible to remove the main coil from the non-boston scientific catheter.No resistance was noted.Microscopic inspection of the main coil was performed and revealed that the zap tip was detached and it was not returned.The interlocking arm was inspected and no anomalies was noted.Dimensional inspection of the primary coil outer diameter (od) was performed and was within specifications.However, dimensional inspection of the number of the number of fiber bundles revealed missing fiber bundles and does not meet specification.The number of fiber bundles fail due to the coil condition.No other issues were identified during the product analysis.
Event or Problem Description
It was reported that the package was contaminated.A 14mmx50cm interlock coil was selected for use on the liver.During preparation, it was noted that the package was contaminated.Both the package seal and the sterility of the device were compromised.The device did not enter the patient's body and the procedure was completed with a different device.No complications were reported and the patient was stable post procedure.

• Brand Name: INTERLOCK
• Common Device Name: DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 10484172
• Report Number: 2134265-2020-12143
• Device Sequence Number: 16822847
• Product Code: KRD
• UDI-Device Identifier: 08714729845294
• UDI-Public: 08714729845294
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K132578
• 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,Followup
• Report Date (Section B): 10/22/2020

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: 07/07/2022
• Device Model Number: 83779
• Device Catalogue Number: 83779
• Device Lot Number: 0024229948
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/21/2020
• Initial Date Received by Manufacturer: 08/21/2020
• Supplement Date Received by Manufacturer: 10/19/2020
• Initial Report FDA Received Date: 09/02/2020
• Supplement Report FDA Received Date: 10/22/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 68 YR
• Patient Weight: 60