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

Model Number 83787

Device Problems Entrapment of Device (1212); Failure to Advance (2524)

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

Event Date 06/17/2023

Event Type  malfunction  

Event Description

It was reported that the coil protruded in the catheter's tip upon removal.A 10mm x 40cm and 15mm x 40cm interlock-35 coils were selected for ventral aorta branch covered stent implantation, left and right internal iliac artery embolization, and aortography.During the procedure, a 15mmx40cm coil was pushed to the neck of the main abdominal tumor, but it could not be further advanced, which could go back but not forward.Embolization could not be completed with the internal iliac artery, so a 10mmx40cm was used to superselect the right iliac through the left femoral artery.However, the first 10cm were smooth, but the position was not suitable and could not be advanced after multiple attempts.Furthermore, when the coils were removed from the patient's body, it was noted that the coils protruded from the tip of the catheter.The procedure was completed with another of the same device.No complications were reported, and the patient was stable post-procedure.

Event Description

It was reported that the coil protruded in the catheter's tip upon removal.A 10mm x 40cm and 15mm x 40cm interlock-35 coils were selected for ventral aorta branch covered stent implantation, left and right internal iliac artery embolization, and aortography.During the procedure, a 15mmx40cm coil was pushed to the neck of the main abdominal tumor, but it could not be further advanced, which could go back but not forward.Embolization could not be completed with the internal iliac artery, so a 10mmx40cm was used to superselect the right iliac through the left femoral artery.However, the first 10cm were smooth, but the position was not suitable and could not be advanced after multiple attempts.Furthermore, when the coils were removed from the patient's body, it was noted that the coils protruded from the tip of the catheter.The procedure was completed with another of the same device.No complications were reported, and the patient was stable post-procedure.

Manufacturer Narrative

Device evaluated by mfr: the complaint device was received for product analysis.The main coil, the introducer and the pusher wire returned for the analysis.Additionally, it was observed the main coil was stretched, detached and bent at the coil arm section and it was observed stretched at the zap tip section.The pouch was returned, and it was observed that the pouch information matches with the complaint information.No more damages can be observed on the device.Under the microscope it was observed that the main coil was stretched, detached and bent at the coil arm section and it was observed stretched at the zap tip section.The functional test could not be performed due the main coil and the pusher wire are not interlocking.Dimensional inspection of the main coil revealed the components were within specifications.No other issues were identified during the product analysis.

• Brand Name: INTERLOCK-35
• Type of Device: DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORK LIMITED; model farm road; cork T12 Y K88; EI T12 YK88
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 17473810
• MDR Text Key: 320575818
• Report Number: 2124215-2023-41649
• 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: Other,Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/26/2023

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 Model Number: 83787
• Device Catalogue Number: 83787
• Device Lot Number: 0030365221
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/12/2023
• Initial Date FDA Received: 08/07/2023
• Supplement Dates Manufacturer Received: 09/06/2023
• Supplement Dates FDA Received: 09/26/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/18/2022
• 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: 72 YR
• Patient Sex: Male
• Patient Weight: 50 KG