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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC - MARLBOROUGH RESOLUTION 360¿ CLIP; HEMOSTATIC METAL CLIP FOR THE GI TRACT
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BOSTON SCIENTIFIC - MARLBOROUGH RESOLUTION 360¿ CLIP; HEMOSTATIC METAL CLIP FOR THE GI TRACT Back to Search Results
Model Number M00521231
Device Problems Detachment Of Device Component (1104); Activation, Positioning or Separation Problem (2906)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/23/2017
Event Type  malfunction  
Manufacturer Narrative
Problem code for the reported issue of hypotube detached.Device code relates to problem code for the reported issue of clip difficult to release from catheter.(b)(4).The device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental mdr will be filed.(b)(4).
 
Event Description
It was reported to boston scientific corporation that a resolution 360 clip device was used during a procedure performed on (b)(6) 2017.According to the complainant, during the procedure, the clip was able to grasp and lock onto tissue but failed to release from the catheter.Eventually, the clip was released after manipulating the handle.Subsequent to successful deployment of the clip, the hypotube came off into the patient and was left to pass naturally.The malfunction was confirmed by a photo sent by the customer showing the hypotube in the patient.The procedure was completed at this time.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.
 
Manufacturer Narrative
Mfg.Site name - (b)(4).Investigation results: a visual examination of the returned complaint device noted that the clip assembly was fully deployed, and the clip was not returned with the device.A kinked was noticed in the control wire near the handle.The hypotube was detached from the control wire and was not returned.This failure is likely due to anatomical/procedural factors encountered during the procedure which limited the performance of the device.Therefore, the most probable root cause is operational context.  a review of the device history record (dhr) was performed and confirmed that this device met all material, assembly and performance specifications.
 
Event Description
It was reported to boston scientific corporation that a resolution 360 clip device was used during a procedure performed on (b)(6) 2017.According to the complainant, during the procedure, the clip was able to grasp and lock onto tissue but failed to release from the catheter.Eventually, the clip was released after manipulating the handle.Subsequent to successful deployment of the clip, the hypotube came off into the patient and was left to pass naturally.The malfunction was confirmed by a photo sent by the customer showing the hypotube in the patient.The procedure was completed at this time.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.
 
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Brand Name
RESOLUTION 360¿ CLIP
Type of Device
HEMOSTATIC METAL CLIP FOR THE GI TRACT
Manufacturer (Section D)
BOSTON SCIENTIFIC - MARLBOROUGH
100 boston scientific way
marlborough MA 01752
Manufacturer Contact
nancy cutino
100 boston scientific way
marlborough, MA 01752
5086834000
MDR Report Key7025842
MDR Text Key92750224
Report Number3005099803-2017-03385
Device Sequence Number1
Product Code PKL
Combination Product (y/n)N
Reporter Country CodeAU
PMA/PMN Number
K151802
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Nurse
Type of Report Initial,Followup
Report Date 10/23/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/13/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date08/20/2020
Device Model NumberM00521231
Device Lot Number0000075397
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/15/2017
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/04/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/08/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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