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

Model Number M00566470

Device Problems Obstruction of Flow (2423); Difficult to Advance (2920)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/07/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).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 push method was used during a percutaneous endoscopic gastrostomy (peg) placement procedure performed on (b)(6) 2018.According to the complainant, during the procedure, the guidewire would not pass in the peg tube near the junction.The guidewire was bent and wobble, it would not fit through.The procedure was completed with a new endovive safety peg kit push method.There were no patient complications reported as a result of this event.Attempts to obtain additional information regarding the circumstances surrounding this event have been unsuccessful to date.Should additional relevant details become available, a supplemental report will be submitted.

Manufacturer Narrative

(device codes): problem code 2423 captures the reportable event of peg tube blocked/occluded.A visual examination of the returned multiple components revealed that the guidewire was received fragmented into four pieces.It appeared to have been cut.The g-tube was also returned and there was no damage observed.The snare was also returned.The cannula in the handle as well as the wire inside the working length was damaged.The complaint was not consistent with the reported event of blocked/occluded peg tube.It is possible that operational factors, such as user handling/technique and patient anatomy, contributed to the damaged snare, and the resulting guidewire passability issue.It is possible that, based on the condition of the fragmented guidewire, the user applied excessive force, resulting in the guidewire not being able to advance; the user likely used a tool to cut the guidewire.Based on all gathered information, the complaint investigation conclusion code selected is adverse event related to procedure, which indicates that the adverse event occurred during the procedure and the device had no influence on event.A dhr (device history record) review was performed and did not identify evidence of deviations or non-conformances in the manufacturing processes that could contribute to the complaint.The dhr review confirms that the accepted device met all manufacturing specifications.

Event Description

It was reported to boston scientific corporation that an endovive safety peg kit push method was used during a percutaneous endoscopic gastrostomy (peg) placement procedure performed on (b)(6) 2018.According to the complainant, during the procedure, the guidewire would not pass in the peg tube near the junction.The guidewire was bent and wobble, it would not fit through.The procedure was completed with a new endovive safety peg kit push method.There were no patient complications reported as a result of this event.Attempts to obtain additional information regarding the circumstances surrounding this event have been unsuccessful to date.Should additional relevant details become available, a supplemental report will be submitted.

• 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: 8139661
• MDR Text Key: 129577801
• Report Number: 3005099803-2018-61828
• Device Sequence Number: 1
• Product Code: KNT
• UDI-Device Identifier: 08714729748397
• UDI-Public: 08714729748397
• 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: 01/08/2019

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 Expiration Date: 03/31/2020
• Device Model Number: M00566470
• Device Catalogue Number: 6647
• Device Lot Number: 0022775950
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/13/2018
• Initial Date Manufacturer Received: 11/08/2018
• Initial Date FDA Received: 12/06/2018
• Supplement Dates Manufacturer Received: 12/12/2018
• Supplement Dates FDA Received: 01/08/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 28 YR