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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION RESOLUTION CLIP; CLIP, HEMOSTATIC
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BOSTON SCIENTIFIC CORPORATION RESOLUTION CLIP; CLIP, HEMOSTATIC Back to Search Results
Model Number M00522610
Device Problem Activation, Positioning or Separation Problem (2906)
Patient Problems Hemorrhage/Bleeding (1888); Discomfort (2330)
Event Date 12/13/2019
Event Type  malfunction  
Manufacturer Narrative
(b)(4).Although the suspect device has been received, the evaluation has not been completed.Therefore, the cause of the reported malfunction has not been determined.Upon 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.
 
Event Description
It was reported to boston scientific corporation that two resolution clip devices were used during a colonoscopy procedure performed on (b)(6) 2019.According to the complainant, during the procedure, the first clip grasped and locked onto tissue, but failed to release from the catheter to deploy.The physician tried several times to maneuver the device, but the clip would still not release.Reportedly, the clip was pulled off by force, leading to increased bleeding.The bleeding was noted to be about 70-80 ml.Then, a second clip was used and was able to grasp and lock onto tissue, but also failed to release from the catheter to deploy.Scissors were used to cut the catheter of the device and the second clip was withdrawn from the patient without any further patient complications.The procedure was completed successfully with a non-bsc clip device.The patient only felt discomfort and the patient condition at the conclusion of the procedure was reported to be stable.
 
Manufacturer Narrative
Block h6: problem code 2906 captures the reportable event of clip failed to release from the catheter.Block h10: investigation results the returned resolution clip device was analyzed, and a visual evaluation noted that the clip assembly was returned attached to the control wire and to the bushing.It was noticed that the spool of the handle was returned detached from the control wire.Additionally, the clip jaws were more exposed than normal and misaligned.No other issues with the device were noted.The reported event was confirmed.This failure is likely due to problems traced to manufacturing process.Therefore, the most probable root cause is manufacturing deficiency.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 two resolution clip devices were used during a colonoscopy procedure performed on (b)(6) 2019.According to the complainant, during the procedure, the first clip grasped and locked onto tissue, but failed to release from the catheter to deploy.The physician tried several times to maneuver the device, but the clip would still not release.Reportedly, the clip was pulled off by force, leading to increased bleeding.The bleeding was noted to be about 70-80 ml.Then, a second clip was used and was able to grasp and lock onto tissue, but also failed to release from the catheter to deploy.Scissors were used to cut the catheter of the device and the second clip was withdrawn from the patient without any further patient complications.The procedure was completed successfully with a non-bsc clip device.The patient only felt discomfort and the patient condition at the conclusion of the procedure was reported to be stable.
 
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Brand Name
RESOLUTION CLIP
Type of Device
CLIP, HEMOSTATIC
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
300 boston scientific way
marlborough MA 01752
MDR Report Key9555815
MDR Text Key189888005
Report Number3005099803-2019-06394
Device Sequence Number1
Product Code PKL
UDI-Device Identifier08714729504795
UDI-Public08714729504795
Combination Product (y/n)N
PMA/PMN Number
K040148
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 04/13/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/06/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date01/21/2022
Device Model NumberM00522610
Device Catalogue Number2261
Device Lot NumberML001789C5
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/06/2020
Date Manufacturer Received03/23/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age72 YR
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