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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION WALLFLEX COLONIC; STENT, COLONIC, METALIC, EXPANDABLE
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BOSTON SCIENTIFIC CORPORATION WALLFLEX COLONIC; STENT, COLONIC, METALIC, EXPANDABLE Back to Search Results
Model Number M00565050
Device Problem Positioning Problem (3009)
Patient Problems No Code Available (3191); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/20/2020
Event Type  Injury  
Manufacturer Narrative
(b)(4).The complainant indicated that the device was contaminated and will not be returned for evaluation; therefore, a failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.
 
Event Description
It was reported to boston scientific corporation on (b)(6) 2020 that a wallflex colonic stent was to be implanted to treat a colonic tumor in the transverse colon during a colonic stenting procedure performed on (b)(6) 2020.Reportedly, the patient's anatomy was tortuous and was not dilated prior to stent placement.According to the complainant, during the procedure, the stent was deployed; however, under endoscopic and x-ray imaging, it was observed that the stent moved out from the desired location.The physician attempted to implant a second stent, however, the stent catheter could not pass through.Reportedly, the patient went to surgery and the stent and the tumor were removed.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.
 
Event Description
It was reported to boston scientific corporation on november 20, 2020 that a wallflex colonic stent was to be implanted to treat a colonic tumor in the transverse colon during a colonic stenting procedure performed on (b)(6) 2020.Reportedly, the patient's anatomy was tortuous and was not dilated prior to stent placement.According to the complainant, during the procedure, the stent was deployed; however, under endoscopic and x-ray imaging, it was observed that the stent moved out from the desired location.The physician attempted to implant a second stent, however, the stent catheter could not pass through.Reportedly, the patient went to surgery and the stent and the tumor were removed.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.The physician attempted to implant a second wallflex colonic stent; however, the delivery system was unable to cross the anatomy due to the patient's anatomy/position of the tumor.It was due to the patient's anatomy that the patient went to surgery to excise the tumor and stent.It was reported that the initial stent was to be implanted as a bridge to surgery.
 
Manufacturer Narrative
Block b5 has been updated with additional information received on february 2, 2021.Block h6: medical device problem code a1502 captures the reportable event of stent positioning problem.Block h10: the complainant indicated that the device was contaminated and will not be returned for evaluation; therefore, a failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.
 
Manufacturer Narrative
Block b5 has been updated with additional information received on january 20, 2021.Block h6: medical device problem code a1502 captures the reportable event of stent positioning problem.Block h10: the complainant indicated that the device was contaminated and will not be returned for evaluation; therefore, a failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.Block h11: block b5 has been corrected to make the event description more robust after review of the record on (b)(6) 2021.
 
Event Description
It was reported to boston scientific corporation on november 20, 2020 that a wallflex colonic stent was to be implanted to treat a colonic tumor in the transverse colon during a colonic stenting procedure performed on (b)(6) 2020.Reportedly, the patient's anatomy was tortuous and was not dilated prior to stent placement.According to the complainant, during the procedure, the stent was deployed; however, under endoscopic and x-ray imaging, it was observed that the stent moved out from the desired location.The physician attempted to implant a second stent, however, the stent catheter could not pass through.Reportedly, the patient went to surgery and the stent and the tumor were removed.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.The physician attempted to implant a second wallflex colonic stent; however, the delivery system was unable to cross the anatomy due to the patient's anatomy/position of the tumor.It was due to the patient's anatomy that the patient went to surgery to excise the tumor and stent.
 
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Brand Name
WALLFLEX COLONIC
Type of Device
STENT, COLONIC, METALIC, EXPANDABLE
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
300 boston scientific way
marlborough MA 01752
MDR Report Key10984247
MDR Text Key220701623
Report Number3005099803-2020-05975
Device Sequence Number1
Product Code MQR
UDI-Device Identifier08714729456520
UDI-Public08714729456520
Combination Product (y/n)N
PMA/PMN Number
K061877
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup,Followup
Report Date 02/10/2021
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? Yes
Device Operator Health Professional
Device Expiration Date08/05/2022
Device Model NumberM00565050
Device Catalogue Number6505
Device Lot Number0025812598
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 11/20/2020
Initial Date FDA Received12/10/2020
Supplement Dates Manufacturer Received01/06/2021
02/02/2021
Supplement Dates FDA Received01/29/2021
02/10/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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