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

Model Number 83786

Device Problems Difficult to Insert (1316); Physical Resistance/Sticking (4012)

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

Event Date 09/29/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(6).Device evaluated by manufacturer: the device was returned for analysis.Only a main coil was returned for this complaint.The introducer sheath was not returned.The delivery wire was not returned.The returned coil was found kinked and severely stretched.Microscopic inspections revealed that the zap tip has a smooth surface and the interlocking arm was detached.For dimensional inspection of the main coil, the number of distal and proximal fiber bundles as well as the overall dimension of the zap tip and the primary coil were within the specifications.

Event Description

Reportable based on device investigations completed on 08dec2021.It was reported that the device could not be delivered in the sheath catheter.The target lesion was located in the abdominal aortic aneurysm.A 12mm x 40cm interlock.035 embolics was selected for use.During the procedure, resistance was encountered and it was noted that the device could not be delivered in the sheath catheter.The device was simply pulled out and the procedure was completed with another of the same device.There were no complications reported and the patient is stable.However, device investigations revealed that the interlocking arm was detached.

• 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: 13090549
• MDR Text Key: 282910796
• Report Number: 2134265-2021-16176
• Device Sequence Number: 1
• Product Code: KRD
• UDI-Device Identifier: 08714729792970
• UDI-Public: 08714729792970
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K133208
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/27/2021

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
• Device Operator: Health Professional
• Device Expiration Date: 05/27/2024
• Device Model Number: 83786
• Device Catalogue Number: 83786
• Device Lot Number: 0027399502
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/02/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/08/2021
• Initial Date FDA Received: 12/27/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/28/2021
• 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
• Patient Age: 51 YR
• Patient Sex: Male
• Patient Weight: 64 KG