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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ENDOVIVE SAFETY PEG KIT; GASTROINTESTINAL TUBES WITH ENTERAL SPECIFIC CONNECTORS
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BOSTON SCIENTIFIC CORPORATION ENDOVIVE SAFETY PEG KIT; GASTROINTESTINAL TUBES WITH ENTERAL SPECIFIC CONNECTORS Back to Search Results
Model Number M00509181
Device Problem Device Contaminated During Manufacture or Shipping (2969)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/04/2023
Event Type  malfunction  
Manufacturer Narrative
The complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.(device codes): imdrf device code a1802 captures the reportable event of foreign matter inside packaging.
 
Event Description
It was reported to boston scientific corporation that a endovive standard peg kit pull method was unpacked on (b)(6) 2023.It was reported that, a hair-like object was found inside the package.Reportedly, there was no patient involved.A new endovive standard peg kit pull method was used to complete the procedure.
 
Event Description
It was reported to boston scientific corporation that a endovive standard peg kit pull method was unpacked on april 04, 2023.It was reported that, a hair-like object was found inside the package.Reportedly, there was no patient involved.A new endovive standard peg kit pull method was used to complete the procedure.
 
Manufacturer Narrative
Block h6 (device codes): imdrf device code a1802 captures the reportable event of foreign matter inside packaging.Block d4 has been updated based on additional information received on 27apr2023.Block h10: one endovive standard peg kit pull method was returned.Visual analysis of the device revealed that a foreign material was found inside the tray.Therefore, the reported complaint is confirmed.Based on the condition of the returned device, engineers determined that the problem observed could be related to manufacturing deficiency.Boston scientific has determined the most probable cause of this complaint is manufacturing deficiency since it was traced to the failure to maintain or establish techniques for controlling and verifying the product specifications (including materials used) identified by the manufacture.
 
Manufacturer Narrative
Block h6 (device codes): imdrf device code a1802 captures the reportable event of foreign matter inside packaging.Block 11: correction: block d4 has been updated based on additional information received on 27apr2023.
 
Event Description
It was reported to boston scientific corporation that a endovive standard peg kit pull method was unpacked on (b)(6) 2023.It was reported that, a hair-like object was found inside the package.Reportedly, there was no patient involved.A new endovive standard peg kit pull method was used to complete the procedure.
 
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Brand Name
ENDOVIVE SAFETY PEG KIT
Type of Device
GASTROINTESTINAL TUBES WITH ENTERAL SPECIFIC CONNECTORS
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
300 boston scientific way
marlborough MA 01752
Manufacturer (Section G)
BOSTON SCIENTIFIC CORPORATION
780 brookside drive
spencer IN 47460
Manufacturer Contact
carole morley
300 boston scientific way
marlborough, MA 01752
5086834015
MDR Report Key16817264
MDR Text Key314038801
Report Number3005099803-2023-02192
Device Sequence Number1
Product Code PIF
Combination Product (y/n)Y
Reporter Country CodeJA
PMA/PMN Number
K150679
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup,Followup
Report Date 06/14/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/26/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberM00509181
Device Catalogue Number57708
Device Lot Number0030172173
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received05/24/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/19/2022
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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