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

Model Number 83786

Device Problem Premature Activation (1484)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/19/2020

Event Type  malfunction  

Manufacturer Narrative

Age at time of event: 18 years or older.Device evaluated by mfr: the device was returned for analysis.A delivery wire, main coil and a non-bsc catheter were returned for this complaint.Visual inspection was performed and the main coil was found kinked and stretched.No more damages were found in the device.Microscopic inspection of the delivery wire was performed and revealed that the proximal end has a smooth surface.The interlocking arm was inspected and no damages was found.Microscopic inspection of the main coil was performed and revealed that the zap tip has a smooth surface.The interlocking arm was inspected and no anomalies was noted.Dimensional inspection of the delivery wire weld outer diameter (od), wire arm od, and wire zap tip were performed and were within specifications.Dimensional inspection of the main coil number of distal fiber bundles, zap tip od, and primary coil od were performed and were within specifications.However, dimensional inspection of the main coil number of proximal fiber bundles revealed missing coil fiber bundles and does not meet specification.The fibers loss was due to the coil condition.No other issues were identified during the product analysis.

Event Description

Reportable based on device analysis completed on 01sep2020.It was reported that the coil detached prematurely in the catheter.An 8mmx40cm interlock-35 coil was selected for use.During the procedure, it was noted that the coil detached when inserting into the catheter.Then, a second coil was selected but also detached inside the catheter.The interlocking arms were dislodged inside the catheter.The procedure was completed with a non-bsc device.No complications were reported and the patient was stable post procedure.However, device analysis revealed missing coil fiber bundles.

• Brand Name: INTERLOCK-35
• Type of Device: DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORK LIMITED; model farm road; cork ; EI
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 10515203
• MDR Text Key: 206348477
• Report Number: 2134265-2020-12510
• Device Sequence Number: 1
• Product Code: KRD
• UDI-Device Identifier: 08714729793014
• UDI-Public: 08714729793014
• Combination Product (y/n): N
• Reporter Country Code: SN
• PMA/PMN Number: K133208
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/10/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/14/2021
• Device Model Number: 83786
• Device Catalogue Number: 83786
• Device Lot Number: 0022119145
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/12/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/01/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/15/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: CATHETER - CORDIS C2