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

Model Number	83786
Medical Device Problem Codes	Break (1069); Difficult to Remove (1528); Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/01/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1.Initial reporter facility name-the (b)(6).
Event or Problem Description
It was reported that the interlock arm was fractured.The non-stenosed target lesion was in the s-shaped tortuous and non-calcified splenic artery.A 18mm x 40cm interlock-35 was selected for use in percutaneous arterial embolization procedure.During delivery, it was noted that the coil could not be pushed or withdraw at the end of the 5f ultrasound catheter.Consequently, after several attempts the interlock arm of the pusher wire fractured.The physician then tried to push the coil outside the body with 0.035 hydrophilic guidewire but failed.The coil never entered the patient, and remained in the catheter the entire time.The procedure was completed with another of the same device.No complications reported and the patient is stable.
Event or Problem Description
It was reported that the interlock arm was fractured.The non-stenosed target lesion was in the s-shaped tortuous and non-calcified splenic artery.A 18mm x 40cm interlock-35 was selected for use in percutaneous arterial embolization procedure.During delivery, it was noted that the coil could not be pushed or withdraw at the end of the 5f ultrasound catheter.Consequently, after several attempts the interlock arm of the pusher wire fractured.The physician then tried to push the coil outside the body with 0.035 hydrophilic guidewire but failed.The coil never entered the patient, and remained in the catheter the entire time.The procedure was completed with another of the same device.No complications reported and the patient is stable.
Additional Manufacturer Narrative
B1.Adverse event/product problem-from adverse event and product problem to product problem.B2.Outcomes attrib to adv event-from required intervention to prevent permanent impairement/damage-not applicable.H1: type of reportable event: corrected from 'serious injury' to 'malfunction'.E1.Initial reporter facility name (b)(6) hospital.
Additional Manufacturer Narrative
Device evaluated by mfr: the device was returned for evaluation.It was observed that the main coil, the introducer sheath and the pusher wire were returned.It was necessary to make two cuts in the introducer sheath to remove the coil.It was observed that the main coil was kinked at the primary coil section.Additionally, the coil was stretched, bent, and detached at the coil arm section.No further damage was observed.Functional testing could not be performed, as the main coil and the pusher wire were not interlocking.Device analysis found damage that would have contributed to the reported events.The customer reported using a non-boston scientific catheter (5f ultrasound), and the use of other diagnostic catheters may result in an inability to deliver, deploy, or recapture the device.B1.Adverse event/product problem-from adverse event and product problem to product problem.B2.Outcomes attrib to adv event-from required intervention to prevent permanent impairement/damage-not applicable.H1: type of reportable event: corrected from 'serious injury' to 'malfunction' e1.Initial reporter facility name- (b)(6).
Event or Problem Description
It was reported that the interlock arm was fractured.The non-stenosed target lesion was in the s-shaped tortuous and non-calcified splenic artery.A 18mm x 40cm interlock-35 was selected for use in percutaneous arterial embolization procedure.During delivery, it was noted that the coil could not be pushed or withdraw at the end of the 5f ultrasound catheter.Consequently, after several attempts the interlock arm of the pusher wire fractured.The physician then tried to push the coil outside the body with 0.035 hydrophilic guidewire but failed.The coil never entered the patient, and remained in the catheter the entire time.The procedure was completed with another of the same device.No complications reported and the patient is stable.
Additional Manufacturer Narrative
H6.Evaluation conclusion codes- from failure to follow instructions to adverse event related to procedure.H10: device evaluated by mfr: the device was returned for evaluation.It was observed that the main coil, the introducer sheath and the pusher wire were returned.It was necessary to make two cuts in the introducer sheath to remove the coil.It was observed that the main coil was kinked at the primary coil section, also was stretched, bent and detached at the coil arm section.No more damages were observed.Functional testing could not be performed due the main coil and the pusher wire were not interlocking.Dimensional inspection revealed that the outer diameter of zap tip and primary coil were within specification.The reported clinical observations of main coil break, main coil unable to advance in catheter and difficult to withdraw from catheter were confirmed due to the device condition.B1.Adverse event/product problem-from adverse event and product problem to product problem.B2.Outcomes attrib to adv event-from required intervention to prevent permanent impairement/damage-not applicable.H1: type of reportable event: corrected from 'serious injury' to 'malfunction.E1.Initial reporter facility name- (b)(6).
Event or Problem Description
It was reported that the interlock arm was fractured.The non-stenosed target lesion was in the s-shaped tortuous and non-calcified splenic artery.A 18mm x 40cm interlock-35 was selected for use in percutaneous arterial embolization procedure.During delivery, it was noted that the coil could not be pushed or withdraw at the end of the 5f ultrasound catheter.Consequently, after several attempts the interlock arm of the pusher wire fractured.The physician then tried to push the coil outside the body with 0.035 hydrophilic guidewire but failed.The coil never entered the patient, and remained in the catheter the entire time.The procedure was completed with another of the same device.No complications reported and the patient is stable.

• Brand Name: INTERLOCK-35
• Common Device Name: DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 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: 18102662
• Report Number: 2124215-2023-61937
• Device Sequence Number: 7891314
• Product Code: KRD
• UDI-Device Identifier: 08714729795414
• UDI-Public: 08714729795414
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K133208
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 02/22/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 06/13/2026
• Device Model Number: 83786
• Device Catalogue Number: 83786
• Device Lot Number: 0031816164
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/02/2023
• Supplement Date Received by Manufacturer: 11/20/2023; 12/18/2023; 01/30/2024
• Initial Report FDA Received Date: 11/09/2023
• Supplement Report FDA Received Date: 12/15/2023; 01/08/2024; 02/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/14/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 5F ULTRASOUND CATHETER; 5F ULTRASOUND CATHETER; 5F ULTRASOUND CATHETER; 5F ULTRASOUND CATHETER
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 55 YR
• Patient Sex: Female
• Patient Weight: 58 KG