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

Model Number M00566490

Device Problems Defective Device (2588); Difficult to Advance (2920)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/03/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).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 mdr will be filed.

Event Description

It was reported to boston scientific corporation that an endovive standard peg kit push method used during a percutaneous endoscopic gastrostomy (peg) placement procedure performed on (b)(6) 2020.According to the complainant, during the procedure, when the physician tried to place the peg tube, a bulge was found.The exact location is unknown, however it was between the dilator tip portion and the bolster.Reportedly due to this it would be difficult to place the peg tube in the patient therefore this device was not used.There were no patient complications reported due to this event.

Event Description

It was reported to boston scientific corporation that an endovive standard peg kit push method used during a percutaneous endoscopic gastrostomy (peg) placement procedure performed on (b)(6), 2020.According to the complainant, during the procedure, when the physician tried to place the peg tube, a bulge was found.The exact location is unknown, however it was between the dilator tip portion and the bolster.Reportedly due to this it would be difficult to place the peg tube in the patient therefore this device was not used.There were no patient complications reported due to this event.Additional information received on (b)(6), 2020: the bulge was found at the transition connector of the push tube.

Manufacturer Narrative

Additional information: b5 block h6 (device codes): problem code 2920 captures the reportable event of peg tube difficult to advance.Block h6 (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 mdr will be filed.

• 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: 9751566
• MDR Text Key: 190608964
• Report Number: 3005099803-2020-00596
• Device Sequence Number: 1
• Product Code: KNT
• UDI-Device Identifier: 08714729748410
• UDI-Public: 08714729748410
• 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: 03/25/2020

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: 06/30/2021
• Device Model Number: M00566490
• Device Catalogue Number: 6649
• Device Lot Number: 0024376620
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/04/2020
• Initial Date FDA Received: 02/25/2020
• Supplement Dates Manufacturer Received: 03/09/2020
• Supplement Dates FDA Received: 03/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1