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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM; PANCREATIC STENT, COVERED, METALLIC, REMOVABLE
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BOSTON SCIENTIFIC CORPORATION AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM; PANCREATIC STENT, COVERED, METALLIC, REMOVABLE Back to Search Results
Model Number M00553560
Device Problem Activation Failure (3270)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/30/2022
Event Type  malfunction  
Manufacturer Narrative
The device has not been received for analysis.Upon receipt and completion of the problem 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 (b)(6) 2022 that an axios stent and electrocautery enhanced delivery system was to be implanted during an endoscopic ultrasound (eus) procedure performed on (b)(6) 2022.During the procedure, the first flange of the stent was deployed without issues; however, the stent first flange failed to expand.The axios stent and electrocautery enhanced delivery system was removed from the patient and the procedure was completed using another axios stent.There were no patient complications reported as a result of this event.The patient condition after the procedure was reported to be fine.
 
Manufacturer Narrative
Block h6: medical device problem code a150101 captures the reportable event of stent first flange failed to expand.Block h10: an axios stent and electrocautery enhanced delivery system were returned for analysis.The stent was received partially deployed with the first flange fully expanded.The delivery system was returned in position "2".Functional inspection was performed and the stent was able to be deployed without problems.Visual examination of the returned device found the inner and outer sheath were kinked at the luer.No other problems were noted to the stent and delivery system.The investigation concluded that the observed failure of inner sheath and outer sheath kinked were likely due to factors encountered during the procedure.It may be that lesion characteristics, how the device was handled, and/or the technique used by the user, limited the performance of the device and contributed to the inner and outer sheath kinked.The reported event of stent first flange failed to expand was not confirmed.Based on the available information, there is not enough information to confirm the reported event of stent first flange failed to expand as the stent first flange was received fully expanded; 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.
 
Event Description
It was reported to boston scientific corporation on (b)(6) 2022 that an axios stent and electrocautery enhanced delivery system was to be implanted during an endoscopic ultrasound (eus) procedure performed on (b)(6) 2022.During the procedure, the first flange of the stent was deployed without issues; however, the stent first flange failed to expand.The axios stent and electrocautery enhanced delivery system was removed from the patient and the procedure was completed using another axios stent.There were no patient complications reported as a result of this event.The patient condition after the procedure was reported to be fine.
 
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Brand Name
AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM
Type of Device
PANCREATIC STENT, COVERED, METALLIC, REMOVABLE
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
300 boston scientific way
marlborough MA 01752
Manufacturer (Section G)
BOSTON SCIENTIFIC CORPORATION
ballybrit business park
galway
EI  
Manufacturer Contact
carole morley
300 boston scientific way
marlborough, MA 01752
5086834015
MDR Report Key14771880
MDR Text Key296136204
Report Number3005099803-2022-03259
Device Sequence Number1
Product Code PCU
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
SIMILAR
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Health Professional,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 08/04/2022
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 Date11/16/2022
Device Model NumberM00553560
Device Catalogue Number5356
Device Lot Number0028392455
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 05/30/2022
Initial Date FDA Received06/22/2022
Supplement Dates Manufacturer Received07/14/2022
Supplement Dates FDA Received08/04/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/16/2021
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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