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

Model Number M00568201

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/14/2020

Event Type  malfunction  

Manufacturer Narrative

Date of event was approximated to (b)(6) 2020 as no event date was reported.(b)(4).The complainant indicated that the device will not be returned for evaluation as it is implanted in the patient; 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 peg kit was used during a esophagogastroduodenoscopy (egd) with percutaneous endoscopic gastrostomy (peg) placement procedure.The procedure date is unknown.According to the complainant, during the procedure, a portion of the peg tube broke.Reportedly, the physician was able to use a grasping device to finish the placement procedure and it was completed with this device.There were no patient complications reported as a result of this event.

Event Description

It was reported to boston scientific corporation that an endovive peg kit was used during a esophagogastroduodenoscopy (egd) with percutaneous endoscopic gastrostomy (peg) placement procedure.The procedure date is unknown.According to the complainant, during the procedure, a portion of the peg tube broke.Reportedly, the physician was able to use a grasping device to finish the placement procedure and it was completed with this device.There were no patient complications reported as a result of this event.Additional information received on september 14, 2020: the procedure date is (b)(6), 2020.The loop wire at the end of the peg tube broke.

Manufacturer Narrative

Block h6 (device codes): problem code 2907 captures the reportable event of peg tube detach.Block h6 (evaluation conclusion codes): the complainant indicated that the device will not be returned for evaluation as it is implanted in the patient; 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.Conclusion code 4316 is being used in lieu of an adequate conclusion code for "device not returned.".

• Brand Name: ENDOVIVE STANDARD PEG KIT
• Type of Device: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 10514698
• MDR Text Key: 206934124
• Report Number: 3005099803-2020-03869
• Device Sequence Number: 1
• Product Code: KNT
• Combination Product (y/n): N
• PMA/PMN Number: K031538
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 10/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/10/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/28/2021
• Device Model Number: M00568201
• Device Catalogue Number: 6820
• Device Lot Number: 0025835966
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 81 YR