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

Model Number M00566460

Device Problem Difficult to Advance (2920)

Patient Problem No Code Available (3191)

Event Date 02/22/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).The reportable event stating that the patient was sent to surgery and a laparoscopy was done to finish the case.(b)(4).The reportable event of peg tube difficult to advance.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 pull method was used during a percutaneous endoscopic gastrostomy (peg) placement procedure performed on (b)(6) 2019.According to the complainant, during the procedure, peg tube did not come through the patient's abdomen and they were unable to pull the device through.Reportedly, the patient was sent to surgery and laparoscopic procedure was performed.The patient's condition at the conclusion of the procedure was reported to be fine.

Manufacturer Narrative

Block h6 (patient codes): patient code 3191 captures the reportable event stating that the patient was sent to surgery and a laparoscopy was done to finish the case.Block h6 (device codes): problem code 2920 captures the reportable event of peg tube difficult to advance.Block h10: visual examination of the returned unit revealed that only a portion of the peg tube was received and the remainder of the peg tube was not returned.Residue was present on the tip of the introducer, indicating signs of use.The pullwire loop on the end peg tube was attached to a portion of the insertion wire loop.The complaint was consistent with the reported incident that the feeding tube was difficult to advance based on the condition of the detached peg tube.It is likely that several factors, such as user technique/handling, patient anatomy, and the size of the incision site that the tube is being pulled through, contributed to the reported complaint.Therefore, 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 the 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.A labeling review was performed and no anomalies were found.

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, peg tube did not come through the patient's abdomen and they were unable to pull the device through.Reportedly, the patient was sent to surgery and laparoscopic procedure was performed.The patient's condition at the conclusion of the procedure was reported to be fine.

• 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: 8422606
• MDR Text Key: 138851611
• Report Number: 3005099803-2019-01272
• Device Sequence Number: 1
• Product Code: KNT
• UDI-Device Identifier: 08714729748380
• UDI-Public: 08714729748380
• 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: 05/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2019
• Device Model Number: M00566460
• Device Catalogue Number: 6646
• Device Lot Number: 22368498
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/04/2019
• Initial Date Manufacturer Received: 02/25/2019
• Initial Date FDA Received: 03/14/2019
• Supplement Dates Manufacturer Received: 04/09/2019
• Supplement Dates FDA Received: 05/03/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other