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

Model Number	83788
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/08/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Age at time of event- 18 years or older.The device was returned for analysis.A delivery wire, coil, introducer sheath and a non-bsc catheter were returned for this complaint.The coil and delivery wire arms were not interlocked.The twist lock of the introducer sheath had been opened, kinked and stretched.The delivery wire was inspected and no anomalies were noted.The coil was inspected and it was found kinked and stretched near the zap tip and along the coil.Many of the fiber bundles were detached.Microscopic inspection of the delivery wire was performed and observed that the zap tip has a smooth surface.The interlocking arm was inspected and no anomalies was noted.Microscopic inspection of the main coil was performed and observed that the zap tip has a smooth surface.The interlocking arm was inspected and no anomalies was noted.The main coil was found kinked and stretched near the zap tip and along the coil.Many of the fiber bundles were detached.Dimensional inspection of the delivery wire that could be measured were performed and were within specification.Dimensional inspection of the zap tip outer diameter (od) and primary coil od was performed and were within specifications.However, there were missing no.Of distal fiber bundles and proximal fiber bundles.
Event or Problem Description
Reportable based on device analysis completed on 25jun2019.It was reported that resistance was felt and the coil became stuck in the catheter.The target lesion was located in the internal iliac artery.An 8mm interlock-35 was selected for use.During procedure, embolization was performed on each of the upper and lower inguinal artery.The procedure was performed under continuous reflux but severe resistance was felt immediately after coil delivery.Subsequently, the coil got stuck in the catheter and was removed together with the delivery wire.A different coil was then used but the same issue occurred and was not resolved.However, device analysis revealed missing coil fiber bundles.

• 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: 8803455
• Report Number: 2134265-2019-08425
• Device Sequence Number: 327268
• Product Code: KRD
• UDI-Device Identifier: 08714729796114
• UDI-Public: 08714729796114
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 07/18/2019

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: 05/31/2020
• Device Model Number: 83788
• Device Catalogue Number: 83788
• Device Lot Number: 0020715098
• 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: 06/25/2019
• Initial Report FDA Received Date: 07/18/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: GUIDE CATHETER- 4FR TEMPO