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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION INTERLOCK-35; DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION
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BOSTON SCIENTIFIC CORPORATION INTERLOCK-35; DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION Back to Search Results
Model Number 83787
Device Problem Failure to Advance (2524)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/26/2023
Event Type  malfunction  
Event Description
Reportable based on device analysis completed on 08dec2023.It was reported that the device could not be pushed at the back end of the catheter.The target lesion was located in the iliac artery.A 10mm x 40cm interlock-35 was selected for use.During the procedure, the device was continuously hydrated before introduction of the coil.The physician used cordis.5f catheter to deploy five bsc coils; two 10x40, and three 8x40 respectively.However, when the first 10x40 was deploy, it could not advance at the middle of the catheter and could not be pushed at the back end of the catheter event after several attempts were made.The device was removed along with the catheter.The procedure was completed with another of same device.No complications were reported, and patient was stable post procedure.However, device analysis revealed that the main coil was detached at the coil arm section.
 
Manufacturer Narrative
E1: initial reporter facility name: (b)(6).Device evaluated by manufacturer: the device was returned for analysis.Visual inspection observed that the main coil was kinked, detached and stretched at the coil arm section.No more damages were observed.The functional could not be performed due the main coil and the pusher wire are not interlocking.Dimensional inspection on the main coil revealed that the zap tip od (outer diameter) and the primary coil od was within specification.
 
Event Description
Reportable based on device analysis completed on 08dec2023.It was reported that the device could not be pushed at the back end of the catheter.The target lesion was located in the iliac artery.A 10mm x 40cm interlock-35 was selected for use.During the procedure, the device was continuously hydrated before introduction of the coil.The physician used cordis.5f catheter to deploy five bsc coils; two 10x40, and three 8x40 respectively.However, when the first 10x40 was deploy, it could not advance at the middle of the catheter and could not be pushed at the back end of the catheter event after several attempts were made.The device was removed along with the catheter.The procedure was completed with another of same device.No complications were reported, and patient was stable post procedure.However, device analysis revealed that the main coil was detached at the coil arm section.
 
Manufacturer Narrative
H6 evaluation conclusion code: corrected e1: initial reporter facility name - (b)(6) h10: additional mfr narrative corrected: device evaluated by manufacturer: the device was returned for analysis.Visual inspection observed that the main coil was kinked, detached and stretched at the coil arm section.No more damages were observed.The functional could not be performed due the main coil and the pusher wire are not interlocking.Dimensional inspection on the main coil revealed that the zap tip od (outer diameter) and the primary coil od was within specification.The reported complaint event main coil unable to advance in catheter is not confirmed since the customer used (cordis5f) and the use of other diagnostic catheters may result in an inability to deliver, deploy, or recapture the device.
 
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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 Key18366052
MDR Text Key331330408
Report Number2124215-2023-72003
Device Sequence Number1
Product Code KRD
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K133208
Number of Events Reported1
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 02/22/2024
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 Number83787
Device Catalogue Number83787
Device Lot Number0031944326
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/27/2023
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 12/08/2023
Initial Date FDA Received12/20/2023
Supplement Dates Manufacturer Received01/30/2024
Supplement Dates FDA Received02/22/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/04/2023
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
MICROCATHETER - 5F CORDIS CATHETER; MICROCATHETER - 5F CORDIS CATHETER
Patient Age52 YR
Patient SexMale
Patient Weight69 KG
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