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

Model Number 83787

Device Problem Difficult to Insert (1316)

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

Event Date 11/22/2022

Event Type  malfunction  

Manufacturer Narrative

Initial reporter facility name: (b)(6).Initial reporter city: (b)(6).Device evaluated by mfr: the device was returned for evaluation.Visual inspection revealed the main coil, introducer sheath and the delivery wire returned.The main coil and the delivery wire were not interlocked; however, both were found inside the introducer sheath.The interlocking arm was detached.The twist lock was opened.The main coil was kinked and stretched.No more damages were observed.It was necessary to make cuts in the introducer sheath in order to free the main coil.Under the microscope was observed that the main coil was detached in the coil arm section.Dimensional inspection of the pusher wire and main coil revealed the components were within specifications.The coil arm overall dimension (od) could not be measured due the interlocking arm was detached.No other issues were identified during the product analysis.

Event Description

Reportable based on device analysis completed on 16mar2023.It was reported that the coil could not be advanced.The target lesion was located in the renal artery.A 15mm x 40cm interlock-35 was selected for use.During preparation, the coil was unlocked.However, the coil could not be advanced.The procedure was completed after a new coil was used.No complications were reported and patient was stable post procedure.However, device analysis 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: jeff wallner ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 16686474
• MDR Text Key: 312760265
• Report Number: 2124215-2023-14401
• Device Sequence Number: 1
• Product Code: KRD
• UDI-Device Identifier: 08714729795438
• UDI-Public: 08714729795438
• 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: 04/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/05/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 83787
• Device Catalogue Number: 83787
• Device Lot Number: 0029286850
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/22/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/16/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/26/2022
• 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: 69 YR
• Patient Sex: Female
• Patient Weight: 58 KG