MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ENDOVIVE SECURI-T; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number M00568151

Device Problems Detachment of Device or Device Component (2907); Human-Device Interface Problem (2949)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/03/2019

Event Type  Injury  

Manufacturer Narrative

The complainant was unable to report the batch/lot number; manufacture date, and expiration date are unknown.(b)(4).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.

Event Description

It was reported to boston scientific corporation that an endovive securi-t percutaneous replacement gastrostomy tube was used during a feeding tube replacement procedure in (b)(6) 2019 exact date is unknown.According to the complainant, post procedure on (b)(6) 2019 it seemed the patient removed the device.The bolster got separated and remained inside the stomach.Reportedly, the detached portion was retrieved via an endoscope.The procedure was completed with a new endovive securi-t percutaneous replacement gastrostomy tube.There was no adverse health damage to the patient.

Manufacturer Narrative

Block d4, h4: the complainant was unable to report the batch/lot number; manufacture date, and expiration date are unknown.Block h6 (device codes): problem code 2907 captures the reportable event of internal bolster detached.Problem code 2949 captures the reportable event of patient removal.Block h6 (evaluation conclusion codes): visual examination of the returned device revealed that the molded internal bolster was detached from the tube.Remnants of the molded internal bolster were observed attached at distal end of the tubing, this indicates that the components were joined prior the separation.The issue occurred post procedure and there were not issues reported during the device placement, this indicates that the device was properly placed without any complication.It is most likely that the device was unintentionally pulled out by the patient and this resulted in tube dislodgement from stoma site, the reported issue of feeding tube patient removal could not be visually/functionally verified therefore it was not confirmed, however,directions for use mentions inadvertent removal as an complication that may occur with the use of direct feeding devices and it is included within the adverse events section of the directions for use.Therefore the investigation conclusion code for the reported event of feeding tube patient removal will be documented as known inherent risk of device ince reported adverse event known and documented in the labeling.If the device was forcible pulled out from the stoma site, this could have contributed with the internal bolster detachment.Probably the molded internal bolster was detached as result of tension forces applied to the device at the moment when it was pulled out of the stoma site, this could have contributed with the event.As per complaint information the was placed in july and was planned to replace on january, hence it is likely that the user pulled the device accidentally or unintentionally and it could have cause the component detachment, therefore the investigation conclusion code for the reported issue of bolster detachment of device or device component will be documented as unintended use error caused or contributed to event since the interaction between the user and device, or sample, caused or contributed to the error.This includes unintended inappropriate use of the device and incorrect sample preparation.Based on the information available and the analysis performed, the investigation conclusion code for the encountered damage will be documented as unintended use error caused or contributed to event since the adverse event occurred post procedure and the device had no influence on event.A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly and performance specifications at the time of release to distribution.A labeling review was performed, and from the information available this device was not used per the directions for use (dfu) product label.The device was removed prior to the planned date.

Event Description

It was reported to boston scientific corporation that an endovive securi-t percutaneous replacement gastrostomy tube was used during a feeding tube replacement procedure in (b)(6) 2019 exact date is unknown.According to the complainant, post procedure on (b)(6) 2019 it seemed the patient removed the device.The bolster got separated and remained inside the stomach.Reportedly, the detached portion was retrieved via an endoscope.The procedure was completed with a new endovive securi-t percutaneous replacement gastrostomy tube.There was no adverse health damage to the patient.

• Brand Name: ENDOVIVE SECURI-T
• Type of Device: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 9512054
• MDR Text Key: 175896831
• Report Number: 3005099803-2019-06216
• Device Sequence Number: 1
• Product Code: KNT
• Combination Product (y/n): N
• PMA/PMN Number: K961345
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 02/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M00568151
• Device Catalogue Number: 6815
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/18/2019
• Date Manufacturer Received: 01/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other