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

Model Number M00566461

Device Problems Detachment of Device or Device Component (2907); Difficult to Advance (2920)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/06/2019

Event Type  malfunction  

Manufacturer Narrative

The complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown at this time.(b)(4).The device has not been received for analysis.Upon receipt and 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 a percutaneous endoscopic gastrostomy (peg) placement procedure performed on (b)(6), 2019.According to the complainant, during the procedure, the physician had difficulty pulling the pullwire of the peg tube through the abdominal wall.The procedure was completed with this device.There were no patient complications reported as a result of this event.

Manufacturer Narrative

The complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown at this time.(device codes): problem code 2920 captures the reportable event of peg tube difficult to place.Problem code 2907 captures the reportable event of peg tube loop wire detached.(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 kit pull method was used during a percutaneous endoscopic gastrostomy (peg) placement procedure performed on (b)(6) 2019.According to the complainant, during the procedure, the physician had difficulty pulling the pullwire of the peg tube through the abdominal wall.The procedure was completed with this device.There were no patient complications reported as a result of this event.Additional information received on 09oct2019: photo of the complaint device indicates that the feeding tube loop wire was detached.

• 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
• MDR Report Key: 9176513
• MDR Text Key: 173215225
• Report Number: 3005099803-2019-04971
• Device Sequence Number: 1
• Product Code: KNT
• UDI-Device Identifier: 08714729802624
• UDI-Public: 08714729802624
• 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: 11/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M00566461
• Device Catalogue Number: 6646
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/22/2019
• Initial Date FDA Received: 10/10/2019
• Supplement Dates Manufacturer Received: 10/09/2019
• Supplement Dates FDA Received: 11/05/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1