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

Model Number M00566470

Device Problem Detachment Of Device Component (1104)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/16/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).The complainant indicated that the device was disposed and will not be returned for evaluation; therefore, a failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.

Event Description

It was reported to boston scientific corporation that an endovive safety peg kit push method was used during an esophagogastroduodenoscopy (egd) with percutaneous endoscopic gastrostomy (peg) placement procedure performed on (b)(6) 2018.According to the complainant, during the procedure, when the physician was pulling the peg tube through the stomach wall, the tube separate at the point where the parts are joint together in the manufacturing process.The detached portion was retrieved and there is no information how it was retrieved.The procedure was completed with a new 24fr peg kit.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 with no harm.

• 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: 7588608
• MDR Text Key: 110672040
• Report Number: 3005099803-2018-01925
• Device Sequence Number: 1
• Product Code: KNT
• UDI-Device Identifier: 08714729748397
• UDI-Public: 08714729748397
• 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
• Report Date: 05/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/11/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 04/30/2019
• Device Model Number: M00566470
• Device Catalogue Number: 6647
• Device Lot Number: 22018367
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/16/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/20/2018
• 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