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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION RESOLUTION 360 ULTRA CLIP; HEMOSTATIC METAL CLIP FOR THE GI TRACT

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BOSTON SCIENTIFIC CORPORATION RESOLUTION 360 ULTRA CLIP; HEMOSTATIC METAL CLIP FOR THE GI TRACT Back to Search Results
Model Number M00521401
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Perforation (2001); Stenosis (2263)
Event Date 10/14/2021
Event Type  Injury  
Event Description
It was reported to boston scientific corporation that a resolution 360 ultra clip device was used in the gastric during a procedure performed on (b)(6) 2021.It was reported that the patient underwent endoscopic myotomy secondary to gastroparesis.It was also found to have severe stenosis involving the pylorus requiring the pyloromyotomy.Mucosal defect closed with five (5) clips followed repeat egd and replacement of the clip followed by ct scan of the abdomen and pelvis showing free fluid and air, followed by diagnostic laparoscopic and repair of the gastric perforation.Boston scientific has been unable to obtain additional information regarding the event to date, despite good faith efforts.
 
Manufacturer Narrative
The complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.Fda registration # mw5104987.(b)(4).The device has not been received for analysis.Should the device become available for analysis and there is any further relevant information, a supplemental medwatch will be filed.
 
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Brand Name
RESOLUTION 360 ULTRA CLIP
Type of Device
HEMOSTATIC METAL CLIP FOR THE GI TRACT
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
300 boston scientific way
marlborough MA 01752
Manufacturer (Section G)
BOSTON SCIENTIFIC DE COSTA RICA S.R.L
2546 calle primera
propark, coyol
alajuela
CS  
Manufacturer Contact
carole morley
300 boston scientific way
marlborough, MA 01752
5086834015
MDR Report Key13224457
MDR Text Key283591834
Report Number3005099803-2022-00058
Device Sequence Number1
Product Code PKL
UDI-Device Identifier08714729997252
UDI-Public08714729997252
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K151802
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 01/11/2022
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? No
Device Operator Health Professional
Device Model NumberM00521401
Device Catalogue Number2140
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 12/13/2021
Initial Date FDA Received01/11/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Type of Device Usage Unknown
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Life Threatening; Required Intervention;
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