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 Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/01/2021

Event Type  Injury  

Manufacturer Narrative

(b)(6).

Event Description

It was reported that the coil prematurely detached inside the patient's body and additional intervention was needed to remove.An 8mmx40cm interlock-35 coil was selected for use on the iliac artery.During the procedure, it was noted that the coil prematurely detached inside the patient's body.The device was removed from the patient's body using a capture device and the procedure was completed with another of the same device.No complications were reported and the patient was stable post procedure.

Manufacturer Narrative

E1 - initial reporter facility name: (b)(6).Device evaluated by mfr: the device was returned for analysis.A delivery wire and introducer sheath were returned for this complaint.The twist lock of the introducer sheath was found opened.The delivery wire was inspected, and no anomalies were noted.The introducer sheath was inspected, and no anomalies were noticed.No damages were found in the device.Microscopic inspection of the delivery wire was performed and revealed that the zap tip has a smooth surface.The interlocking arm was inspected, and no anomalies were noticed.Dimensional inspection of the delivery wire was performed and the measured dimensions were within specification.No issues were identified during the product analysis.

Event Description

It was reported that the coil prematurely detached inside the patient's body and additional intervention was needed to remove.An 8mmx40cm interlock-35 coil was selected for use on the iliac artery.During the procedure, it was noted that the coil prematurely detached inside the patient's body.The device was removed from the patient's body using a capture device and the procedure was completed with another of the same device.No complications were reported and the patient was stable post procedure.It was further reported that the physician used a non-boston scientific catheter to deliver the coil.Because the vessel was too tortuous, the coil could not be delivered.It was found detached when it was withdrawing.After withdrawing the coil and the catheter, the physician used an interlock coil to finish the procedure.The patient is stable.

• 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
• MDR Report Key: 11939314
• MDR Text Key: 254284942
• Report Number: 2134265-2021-07031
• Device Sequence Number: 1
• Product Code: KRD
• UDI-Device Identifier: 08714729793014
• UDI-Public: 08714729793014
• Combination Product (y/n): N
• PMA/PMN Number: K133208
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 07/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/25/2023
• Device Model Number: 83786
• Device Catalogue Number: 83786
• Device Lot Number: 0025269704
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/10/2021
• Initial Date Manufacturer Received: 05/25/2021
• Initial Date FDA Received: 06/04/2021
• Supplement Dates Manufacturer Received: 06/23/2021
• Supplement Dates FDA Received: 07/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CATHETER - CORDIS 5F
• Patient Outcome(s): Required Intervention
• Patient Age: 57 YR
• Patient Weight: 65