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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ENDOVIVE STANDARD PEG KIT; TUBES, GASTROINTESTINAL (AND ACCESSORIES)
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BOSTON SCIENTIFIC CORPORATION ENDOVIVE STANDARD PEG KIT; TUBES, GASTROINTESTINAL (AND ACCESSORIES) Back to Search Results
Model Number M00568390
Device Problem Device Contaminated During Manufacture or Shipping (2969)
Patient Problem No Patient Involvement (2645)
Event Date 10/09/2020
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 mdr will be filed.
 
Event Description
It was reported to boston scientific corporation that an endovive standard peg kit pull method was unpacked.Event date is unknown.According to the complainant, a hair was found inside the unopened sterile package.Reportedly, there was no patient involved.
 
Manufacturer Narrative
Block h6 (device codes): problem code 2969 captures the reportable event of foreign matter inside packaging.Block h10: a visual examination of the device revealed that the device returned is in its sealed pouch, the heat seal runs throughout entire length of the tray without any breakage.A hair was observed inside the package.The reported complaint was confirmed.Therefore, it was concluded based on the information available and the analysis performed to the returned device that the investigation conclusion code for this complaint will be documented as quality control deficiency due to problems traced to the failure to maintain or establish techniques for controlling and verifying the product specifications (including materials used) identified by the manufacturer himself.There is no evidence of nonconforming product that is outside of boston scientific control.The investigation to address this issue has been completed.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 standard peg kit pull method was unpacked.Event date is unknown.According to the complainant, a hair was found inside the unopened sterile package.Reportedly, there was no patient involved on this event.
 
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Brand Name
ENDOVIVE STANDARD PEG KIT
Type of Device
TUBES, GASTROINTESTINAL (AND ACCESSORIES)
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
300 boston scientific way
marlborough MA 01752
MDR Report Key10759136
MDR Text Key214165965
Report Number3005099803-2020-05016
Device Sequence Number1
Product Code KNT
Combination Product (y/n)N
PMA/PMN Number
K031538
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 12/21/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/29/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date03/02/2023
Device Model NumberM00568390
Device Catalogue Number6839S
Device Lot Number0025292793
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/02/2020
Date Manufacturer Received12/02/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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