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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 Problems Entrapment of Device (1212); Detachment of Device or Device Component (2907)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/26/2021
Event Type  Injury  
Manufacturer Narrative
(b)(4).The device has not been received for analysis.Upon completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.
 
Event Description
It was reported to boston scientific corporation on january 27, 2021 that a wallflex colonic stent was implanted to treat colon cancer during a colonoscopy with colonic stent placement procedure performed on (b)(6) 2021.It was reported that during the procedure, the stent was deployed inside the patient.However, during removal of the guidewire, the guidewire became stuck and a piece of the delivery system detached inside the patient.Reportedly, the guidewire took about an hour to remove.The detached piece of the delivery system was removed from the patient with rat tooth forceps.The stent remains implanted and the procedure was completed.There were no patient complications reported as a result of this event.
 
Event Description
It was reported to boston scientific corporation on january 27, 2021 that a wallflex colonic stent was implanted to treat colon cancer during a colonoscopy with colonic stent placement procedure performed on (b)(6) 2021.It was reported that during the procedure, the stent was deployed inside the patient.However, during removal of the guidewire, the guidewire became stuck and a piece of the delivery system detached inside the patient.Reportedly, the guidewire took about an hour to remove.The detached piece of the delivery system was removed from the patient with rat tooth forceps.The stent remains implanted and the procedure was completed.There were no patient complications reported as a result of this event.
 
Manufacturer Narrative
Block h6: medical device problem code a0501 captures the reportable event of inner shaft/sheath detached.Block h10: a wallflex colonic stent delivery system was received for analysis; the stent was not returned.The device was returned with a non-bsc mandrel.Visual examination of the returned device found the outer clear sheath was accordioned/buckled.No other issues were noted to the delivery system.The damaged noted to the outer sheath (buckled/accordioned) may have been a result of an excessive force applied to the delivery system during used.The reported event of inner shaft/sheath detachment of device or device component was not confirmed as the inner sheath was returned in good condition.Additionally device guidewire stuck cannot be confirmed; most likely, these failures were due to procedural factors encountered during the procedure.It may be that the interaction of the device with the scope, the techniques used by the user and/or the patient anatomy, limited the performance of the device and contributed to the stuck guidewire.When the physician attempted to remove the guidewire, the stainless steel tube might have compressed the inner member and caused the guidewire to become stuck.However, these failures could not confirmed during product analysis.Additionally, the customer reported that a piece of the delivery system detached inside the patient; however, there was no confirmation on what the customer indicated because the device was inspected and included all the ro markers, the inner and outer sheath.Therefore, a review and analysis of all available information indicated the most probable cause is no problem detected.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.A labeling review was performed, and from the information available, this device was used per the instructions for use (ifu)/ product label.
 
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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 Key11343510
MDR Text Key232384359
Report Number3005099803-2021-00639
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,health
Type of Report Initial,Followup
Report Date 03/22/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/18/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date07/25/2021
Device Model NumberM00565050
Device Catalogue Number6505
Device Lot Number0024170863
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/19/2021
Date Manufacturer Received02/26/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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