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

Model Number	M00566490
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Death (1802); Peritonitis (2252)
Date of Event	11/25/2020
Type of Reportable Event	Death
Additional Manufacturer Narrative
(b)(4).The complainant indicated that the device was disposed and will not be returned for evaluation; therefore, a problem analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.
Event or Problem Description
Note: this report pertains to one of two devices used during the same procedure.Refer to manufacturer report# 3005099803-2020-06245 for the first endovive safety peg push method and manufacturer report# 3005099803-2020-06244 for the second endovive safety peg push method.It was reported to boston scientific corporation that an endovive safety peg push method was placed during a percutaneous endoscopic gastrostomy (peg) placement procedure performed on (b)(6) 2020.According to the complainant, during the procedure, as they were pulling the peg tube through the stoma, the peg tube detached.The detached peg tube was retrieved using a snare.A second endovive safety peg push method was opened and used; however, the same thing happened.After the second attempted placement of the peg tube the stomach could no longer be insufflate.It was noted that the air was escaping into the cavity (stomach wall).The procedure was stopped because the physician could no longer insufflate.In lieu of the peg tube, a nasogastric (ng) tube was inserted into the patient.Reportedly, the patient developed pneumoperitonitis.It could not be confirmed if the pneumoperitonitis was treated.On (b)(6) 2020, the patient died.There is no information regarding the cause of the patient's death, and autopsy results were not made available.Reportedly the patient had cancer.
Event or Problem Description
Note: this report pertains to one of two devices used during the same procedure.Refer to manufacturer report# 3005099803-2020-06245 for the first endovive safety peg push method and manufacturer report# 3005099803-2020-06244 for the second endovive safety peg push method.It was reported to boston scientific corporation that an endovive safety peg push method was placed during a percutaneous endoscopic gastrostomy (peg) placement procedure performed on (b)(6) 2020.According to the complainant, during the procedure, as they were pulling the peg tube through the stoma, the peg tube detached.The detached peg tube was retrieved using a snare.A second endovive safety peg push method was opened and used; however, the same thing happened.After the second attempted placement of the peg tube the stomach could no longer be insufflate.It was noted that the air was escaping into the cavity (stomach wall).The procedure was stopped because the physician could no longer insufflate.In lieu of the peg tube, a nasogastric (ng) tube was inserted into the patient.Reportedly, the patient developed pneumoperitonitis.It could not be confirmed if the pneumoperitonitis was treated.On (b)(6) 2020, the patient died.There is no information regarding the cause of the patient's death, and autopsy results were not made available.Reportedly the patient had cancer.
Additional Manufacturer Narrative
Block h6 (patient codes): problem code 2252 captures the reportable event of peritonitis.Problem code 1802 captures the reportable event of death.Block h6 (device codes): problem code 2907 captures the reportable event of peg tube detached.Block h10: the complainant indicated that the device was disposed and will not be returned for evaluation; therefore, a problem analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.Block h11 (correction): the manufacturing site address in section g has been corrected (mfr site address 1, mfr site city, mfr site state, mfr site zip/post code).

• Brand Name: ENDOVIVE SAFETY PEG KIT
• Common Device Name: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 11049616
• Report Number: 3005099803-2020-06245
• Device Sequence Number: 19091086
• Product Code: KNT
• UDI-Device Identifier: 08714729748410
• UDI-Public: 08714729748410
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: K031538
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/20/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 11/30/2021
• Device Model Number: M00566490
• Device Catalogue Number: 6649
• Device Lot Number: 0026081004
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/25/2020
• Supplement Date Received by Manufacturer: 01/20/2021
• Initial Report FDA Received Date: 12/21/2020
• Supplement Report FDA Received Date: 01/21/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death; Other
• Patient Age: 68 YR