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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC - SPENCER ENDOVIVE¿ SAFETY PEG KIT; TUBES, GASTROINTESTINAL (AND ACCESSORIES)
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BOSTON SCIENTIFIC - SPENCER ENDOVIVE¿ SAFETY PEG KIT; TUBES, GASTROINTESTINAL (AND ACCESSORIES) Back to Search Results
Model Number M00566460
Device Problem Difficult to Advance (2920)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/19/2015
Event Type  malfunction  
Event Description
It was reported to boston scientific corporation that an endovive safety peg kit pull method was used during an esophagogastroduodenoscopy with percutaneous endoscopic gastrostomy placement procedure performed on (b)(6) 2015.According to the complainant, during the procedure, while the physician was pulling the peg tube through the stomach, the peg tube would not come through the gastric wall.The physician had to use extreme force.Reportedly, the incision size is "normal" (exact size unknown.) the procedure was completed with this endovive safety peg kit pull method.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 okay.
 
Manufacturer Narrative
Reported event of peg tube difficulty placing/retracting.The device has 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.
 
Manufacturer Narrative
A visual examination of the returned device revealed that it had been cut at approximately 3.4 cm from the outer ring.The wire loop at the end of the dilating tip had been cut off adjacent to the tip and the proximal portion of the loop was not returned.The device did not present any unusual ridges in the transition area.No surface defects were noted and the tubing appears to be properly extruded.The distal portion of the feeding tube including the bolster, was not returned.It was noted that the condition of the returned device could not be functionally evaluated with respect to feeding tube difficulty placing during the procedure.Based on all gathered information, the most probable root cause is "operational context." a review of the device history record (dhr) lot number 17771263 was performed; no anomalies were noted.
 
Event Description
It was reported to boston scientific corporation that an endovive safety peg kit pull method was used during an esophagogastroduodenoscopy with percutaneous endoscopic gastrostomy placement procedure performed on (b)(6) 2015.According to the complainant, during the procedure, while the physician was pulling the peg tube through the stomach, the peg tube would not come through the gastric wall.The physician had to use extreme force.Reportedly, the incision size is "normal" (exact size unknown.) the procedure was completed with this endovive safety peg kit pull method.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 okay.
 
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Brand Name
ENDOVIVE¿ SAFETY PEG KIT
Type of Device
TUBES, GASTROINTESTINAL (AND ACCESSORIES)
Manufacturer (Section D)
BOSTON SCIENTIFIC - SPENCER
780 brookside drive
spencer IN 47460
Manufacturer (Section G)
BOSTON SCIENTIFIC - SPENCER
780 brookside drive
spencer IN 47460
Manufacturer Contact
nancy cutino
100 boston scientific way
marlborough, MA 01752
5086834000
MDR Report Key4916348
MDR Text Key16561076
Report Number3005099803-2015-01963
Device Sequence Number1
Product Code KNT
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K031538
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative,company representative
Reporter Occupation Other
Type of Report Initial
Report Date 06/23/2015
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 Physician
Device Expiration Date06/30/2016
Device Model NumberM00566460
Device Catalogue Number6646
Device Lot Number17771263
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/14/2015
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 06/23/2015
Initial Date FDA Received07/15/2015
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/09/2015
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Age59 YR
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