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 12/09/2022

Event Type  malfunction  

Manufacturer Narrative

Device evaluated by mfr: the complaint device was received for product analysis.The main coil, the delivery wire, the introducer sheath, and the rotating hemostatic valve were returned.Twist lock was opened.The main coil was found stretched, kink and the interlocking arm detached.The main coil returned separated of the delivery wire, and for this reason the functional inspection could not be performed.Under magnification it was possible to observe the interlocking arm detached.No other issues were identified during the product analysis.

Event Description

Reportable based on device analysis completed on (b)(6) 2023.It was reported that the coil was stuck at the mouth of the catheter.A 15mmx40cm interlock-35 coil was selected for use on a 2cm arterial aneurysm.During the procedure, the physician could not deliver the device into the catheter, and the device was stuck at the mouth of the catheter.The procedure was completed with another of the same device.No complications were reported and the patient was stable post procedure.However, device analysis revealed a detached interlocking arm.

• 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 ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 16383385
• MDR Text Key: 309643817
• Report Number: 2124215-2023-06339
• 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: 02/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2023
• 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: 0029386286
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/06/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/24/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/12/2022
• 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
• Treatment: ANGIOGRAPHY CATHETER - CORDIS 5F.
• Patient Age: 55 YR
• Patient Sex: Male