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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 Problems Defective Device (2588); Difficult to Advance (2920)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/23/2020
Event Type  malfunction  
Manufacturer Narrative
(b)(6).(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 a resolution clip device was used in the intestinal tract during an endoscopic submucosal dissection (esd) procedure performed on (b)(6) 2020.According to the complainant, during the procedure, the connection between the clip and catheter was observed to be bent.Reportedly, it was noted that the clip was difficult to advance out of the over-sheath.The procedure was completed with another resolution clip device.There were no patient complications reported as a result of this event.The patient condition at the conclusion of the procedure was reported to be stable.
 
Manufacturer Narrative
Block e1: initial reporter facility name: dongguan hospital of traditional chinese medicine block h6: device code 2588 captures the reportable event of the bushing bent.Block h10: investigaton results: the returned resolution clip device was analyzed, and a visual evaluation noted that the clip assembly was partially separated from the bushing, as the control wire was still attached to the clip assembly.Microscope examination was performed and it was noted that the capsule tabs were damaged; however, no evidence of activations that had been performed in the clip assembly.Additionally, due to the condition of the most distal section of the device, it was not possible to pass the sheath through the clip assembly.Functional evaluation could not be performed due to the device returned condition.The reported event was not confirmed.This failure is likely due to factors or conditions related to procedure during the use of the device that could have affected its performance and its intended purpose.Therefore, the most probable root cause is adverse event related to procedure.A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly and performance specifications.A labeling review was performed and, from the information available, this device was used per the directions for use (dfu)/product label.
 
Event Description
It was reported to boston scientific corporation that a resolution clip device was used in the intestinal tract during an endoscopic submucosal dissection (esd) procedure performed on june 23, 2020.According to the complainant, during the procedure, the connection between the clip and catheter was observed to be bent.Reportedly, it was noted that the clip was difficult to advance out of the over-sheath.The procedure was completed with another resolution clip device.There were no patient complications reported as a result of this event.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 Key10298637
MDR Text Key199869801
Report Number3005099803-2020-02830
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 09/01/2020
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 Expiration Date10/09/2021
Device Model NumberM00522610
Device Catalogue Number2261
Device Lot NumberML001736C5
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/14/2020
Initial Date Manufacturer Received 06/24/2020
Initial Date FDA Received07/20/2020
Supplement Dates Manufacturer Received08/10/2020
Supplement Dates FDA Received09/01/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age62 YR
Patient Weight55
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