MAUDE Adverse Event Report: BOSTON SCIENTIFIC - MARLBOROUGH ENDOVIVE¿ SAFETY PEG KIT; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number M00566460

Device Problem Detachment Of Device Component (1104)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/07/2018

Event Type  Injury  

Manufacturer Narrative

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¿ safety peg kit pull method was used during an upper endoscopy with percutaneous endoscopic gastrostomy (peg) placement procedure performed on (b)(6) 2018.According to the complainant, on (b)(6) 2018, the patient came back claiming the peg tube was hissing.They attempted to remove the tube however, it broke in half as if the internal bolster broke off inside the patient and the external bolster came out of the skin.Upper endoscopy was performed to retrieve the detached portion.The procedure was completed with a new endovive¿ safety peg kit pull method.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be fine.

Manufacturer Narrative

A visual examination of the returned device revealed that the internal bolster was detached from the tube, confirming the complaint.There appears to be residue on the distal end of the tube from the bolster-tube bond.The complaint was consistent with the reported incident that the bolster detached/separated.Operational factors likely contributed to the event, such as excessive force may be applied when removing the peg tube.Therefore, the most probable root cause of 'operational context' is selected for the complaint.The complaint investigation conclusion code selected is operational context, which indicates that the complaint is associated with a product that meets the design and manufacturing specifications but due to anatomical/procedural factors encountered during the procedure, performance was limited.A dhr (device history record) review was performed and no deviation was found.A search of the complaint database confirmed that no similar complaints exist for the specified batch.A labeling review was performed and no anomalies were found.

Event Description

It was reported to boston scientific corporation that an endovive safety peg kit pull method was used during an upper endoscopy with percutaneous endoscopic gastrostomy (peg) placement procedure performed on (b)(6) 2018.According to the complainant, on (b)(6) 2018, the patient came back claiming the peg tube was hissing.They attempted to remove the tube however, it broke in half as if the internal bolster broke off inside the patient and the external bolster came out of the skin.Upper endoscopy was performed to retrieve the detached portion.The procedure was completed with a new endovive safety peg kit pull method.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be fine.

• Brand Name: ENDOVIVE¿ SAFETY PEG KIT
• Type of Device: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): BOSTON SCIENTIFIC - MARLBOROUGH; 100 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC - MARLBOROUGH; 100 boston scientific way; marlborough MA 01752
• Manufacturer Contact: nancy cutino ; 100 boston scientific way; marlborough, MA 01752 ; 5086834000
• MDR Report Key: 7538228
• MDR Text Key: 109054704
• Report Number: 3005099803-2018-01673
• Device Sequence Number: 1
• Product Code: KNT
• UDI-Device Identifier: 08714729748380
• UDI-Public: 08714729748380
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K031538
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/23/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2019
• Device Model Number: M00566460
• Device Catalogue Number: 6646
• Device Lot Number: 21747334
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/14/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/13/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/14/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other