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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 Failure to Advance (2524); Activation, Positioning or Separation Problem (2906)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/01/2023
Event Type  malfunction  
Event Description
It was reported to boston scientific corporation that a resolution clip device was used during a colonoscopy procedure performed on (b)(6) 2023.During the procedure, the clip did not deploy from the catheter despite the proper techniques for deployment were initiated.The procedure was completed with another resolution clip.There were no patient complications reported as a result of this event.
 
Manufacturer Narrative
Patient's exact age is unknown; however, it was reported that the patient was over the age of 18.The complainant was unable to provide the correct device lot number; therefore, the lot expiration and device manufacture dates are unknown.Initial reporter's alternative phone number: (b)(6).Imdrf device code captures the reportable event of clip did not deploy from catheter.
 
Manufacturer Narrative
Block a2: patient's exact age is unknown; however, it was reported that the patient was over the age of 18.Block d4, h4: the complainant was unable to provide the correct device lot number; therefore, the lot expiration and device manufacture dates are unknown.Block h2: additional information: block b5 (describe event or problem), e1 (initial reporter first name, phone number and email), h6 (device codes) and h10 (additional mfr narrative) have been updated based on the additional information received on april 3, 2023.Block h6: imdrf device code a15 captures the reportable event of clip did not deploy from catheter.
 
Event Description
It was reported to boston scientific corporation that a resolution clip device was used during a colonoscopy procedure performed on (b)(6) 2023.During the procedure, the clip did not deploy from the catheter despite the proper techniques for deployment were initiated.The procedure was completed with another resolution clip.There were no patient complications reported as a result of this event.Additional information received on april 3, 2023: note: this report pertains to one of two resolution clips used in the same patient and procedure.It was reported that the procedure performed was a routine colonoscopy procedure.Both clips had problems advancing out of the over sheath.When the clips eventually were able to advance out of the sheath, the clips did not fire properly.
 
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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
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 Key16620386
MDR Text Key312316474
Report Number3005099803-2023-01559
Device Sequence Number1
Product Code PKL
UDI-Device Identifier08714729504795
UDI-Public08714729504795
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K222503
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 04/28/2023
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 NumberM00522610
Device Catalogue Number2261
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 03/02/2023
Initial Date FDA Received03/27/2023
Supplement Dates Manufacturer Received04/03/2023
Supplement Dates FDA Received04/28/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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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