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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ENDOVIVE REPL BUTTON K W/ENFIT 24F 3.4CM; GASTROINTESTINAL TUBES WITH ENTERAL SPECIFIC CONNECTORS
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BOSTON SCIENTIFIC CORPORATION ENDOVIVE REPL BUTTON K W/ENFIT 24F 3.4CM; GASTROINTESTINAL TUBES WITH ENTERAL SPECIFIC CONNECTORS Back to Search Results
Model Number M00509470
Device Problem Material Integrity Problem (2978)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/13/2021
Event Type  malfunction  
Manufacturer Narrative
(b)(4).The device has not been received for analysis.Upon receipt and 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 that an endovive repacement button used during a percutaneous endoscopic gastrostomy (peg) replacement procedure on (b)(6) 2021.During procedure closure, the internal bolster was torn and a hole was opened.The procedure was completed with a new endovive repacement button.There were no patient complications reported as a result of this event.
 
Manufacturer Narrative
Block e1: this event was reported by the distributor.The physician is: dr (b)(6).Block h6 (device codes): problem code a0414 captures the reportable event of endovive repacement button internal bolster damaged.Block h6 (evaluation conclusion codes): the device has not been received for analysis.Upon receipt and 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 that an endovive replacement button used during a percutaneous endoscopic gastrostomy (peg) replacement procedure on (b)(6) 2021.During procedure closure, the internal bolster was torn and a hole was opened.The procedure was completed with a new endovive repacement button.There were no patient complications reported as a result of this event.
 
Manufacturer Narrative
Correction: block e1 (initial reporter facility name) block e1: this event was reported by the distributor.The physician is: dr.(b)(6).Phone: (b)(6).Fax: (b)(6).(b)(6) medical center.(b)(6).Block h6 (device codes): problem code a0414 captures the reportable event of endovive repacement button internal bolster damaged.Block h10: the returned endovive repacement button was analyzed, and a visual evaluation noted that there was no problem with the internal bolster that was previously reported as torn and a hole was opened.No other issues with the device were noted.The reported event was not confirmed.Based on the condition of the returned device, engineers determined that the failure mode reported was not observed.Boston scientific has determined the most probable cause of this complaint is no problem detected since the device complaint or problem cannot be confirmed.The complainant did confirm the correct device was returned.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 that an endovive repacement button used during a percutaneous endoscopic gastrostomy (peg) replacement procedure on (b)(6) 2021.During procedure closure, the internal bolster was torn and a hole was opened.The procedure was completed with a new endovive repacement button.There were no patient complications reported as a result of this event.
 
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Brand Name
ENDOVIVE REPL BUTTON K W/ENFIT 24F 3.4CM
Type of Device
GASTROINTESTINAL TUBES WITH ENTERAL SPECIFIC CONNECTORS
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
300 boston scientific way
marlborough MA 01752
MDR Report Key12391634
MDR Text Key268920648
Report Number3005099803-2021-04497
Device Sequence Number1
Product Code PIF
Combination Product (y/n)Y
PMA/PMN Number
K161003
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Type of Report Initial,Followup,Followup
Report Date 10/21/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/31/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberM00509470
Device Catalogue Number57776
Device Lot Number0027537957
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/22/2021
Date Manufacturer Received10/05/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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