MAUDE Adverse Event Report: BOSTON SCIENTIFIC - COSTA RICA (COYOL) ENDOVIVE¿ SECURI-T¿; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number M00568151

Device Problem Detachment Of Device Component (1104)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/25/2018

Event Type  Injury  

Manufacturer Narrative

The complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.However, the complainant reported that the device was not expired.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 gastrostomy replacement procedure performed in (b)(6) 2017 (exact day is unknown.) according to the complainant, during the removal of the device on (b)(6) 2018, the internal bolster detached from the tube.Reportedly, the detached portion was retrieved using an endoscope and grasping forceps.The procedure was completed with a new endovive¿ securi-t percutaneous replacement gastrostomy tube.There were no patient complications reported due to this event.

Event Description

It was reported to boston scientific corporation that an endovive¿ securi-t percutaneous replacement gastrostomy tube was used during a gastrostomy replacement procedure performed in november 2017 (exact day is unknown.) according to the complainant, during the removal of the device on (b)(6) 2018, the internal bolster detached from the tube.Reportedly, the detached portion was retrieved using an endoscope and grasping forceps.The procedure was completed with a new endovive¿ securi-t percutaneous replacement gastrostomy tube.There were no patient complications reported due to this event.

Manufacturer Narrative

A visual examination of the returned device revealed that the bolster was found to be separated from the device.The distal end of the tubing presented no tearing.There were no defects found in the internal bolster that might have contributed to the failure.It appears that the internal bolster was securely molded to the tubing.The complaint was consistent with the reported incident that the bolster detached/separated.Bolster detachment during removal most likely occurred because the excess force was applied to the device during removal causing the bond between the tubing and bolster fail.Therefore, taking into consideration all this factor the most probable cause of this complaint will be documented as "operational context¿, due to anatomical and/or procedural factors encountered during the procedure the performance of the device was limited.A labeling review was performed and no anomalies were found.

• Brand Name: ENDOVIVE¿ SECURI-T¿
• Type of Device: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): BOSTON SCIENTIFIC - COSTA RICA (COYOL); 2546 first street; propark free zone; alajuela ; CS
• MDR Report Key: 7618420
• MDR Text Key: 111623667
• Report Number: 3005099803-2018-02074
• 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: 05/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/20/2018
• 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: 05/31/2018
• Date Manufacturer Received: 06/26/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other