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

Model Number 83787

Device Problem Premature Activation (1484)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/14/2021

Event Type  malfunction  

Manufacturer Narrative

Device evaluated by mfr: the device was returned for evaluation.Visual inspection revealed that a main coil, introducer sheath and delivery wire were returned for this complaint.The coil and delivery wire were not interlocked within introducer sheath.The delivery wire returned inside introducer sheath.The twist lock had been opened.The coil was out of the introducer sheath, and was found kinked and stretched.The delivery wire was inspected, and it was found kinked.No more damages were found.Functional inspection revealed that the delivery wire was advanced through the introducer sheath, no resistance was noticed.Microscopic inspection of the delivery wire 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 revealed that the zap tip has a smooth surface.The interlocking arm was inspected, and no damages was found.Dimensional inspection of the delivery wire and main coil revealed the components were within specification except the number of proximal fiber bundles, which were less than specification.

Event Description

Reportable based on device analysis completed on 11may2021.It was reported that the coil got early detached in the catheter.The target lesion was located in the severely tortuous and severely calcified abdominal aneurysm.A 10mm x 40cm interlock-35 was selected for use.During procedure, it was noted that the coil got early detached in the middle part of the catheter.The coil was removed together with the catheter and the procedure was completed with a different device.No patient complications were reported.However, device analysis revealed that there was missing 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: 11914624
• MDR Text Key: 253564272
• Report Number: 2134265-2021-06666
• Device Sequence Number: 1
• Product Code: KRD
• UDI-Device Identifier: 08714729795513
• UDI-Public: 08714729795513
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K133208
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/01/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/09/2021
• Device Model Number: 83787
• Device Catalogue Number: 83787
• Device Lot Number: 0022355404
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/06/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/11/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/10/2018
• 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