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

Model Number M00566460

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/31/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Evaluation conclusion codes: 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 pull method was placed during an esophagogastroduodenoscopy (egd) with percutaneous endoscopic gastrostomy (peg) placement procedure performed on (b)(6) 2020.According to the complainant, during the procedure, the pull wire on the end of the peg tube broke.The procedure was completed with this device.There were no reported patient complications as a result of this event.

• Brand Name: ENDOVIVE SAFETY PEG KIT
• Type of Device: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 500 commander shea boulevard; quincy MA 02171
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 10620070
• MDR Text Key: 209597581
• Report Number: 3005099803-2020-04378
• 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
• Report Date: 10/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/02/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2021
• Device Model Number: M00566460
• Device Catalogue Number: 6646
• Device Lot Number: 0025890051
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/15/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/12/2019
• 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