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

Model Number M00566521

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Inflammation (1932); Internal Organ Perforation (1987)

Event Date 12/13/2019

Event Type  Injury  

Manufacturer Narrative

(b)(6).The complainant was unable to report the upn and batch/lot number; manufacture date, and expiration date are unknown.(b)(4).The complainant indicated that the device will not be returned for evaluation as it is implanted in the patient; 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 was used during a percutaneous endoscopic gastrostomy (peg) placement procedure (b)(6) 2019.According to the complainant, after placement of the peg, blood adhered in the esophagus as shown in the endoscope.A computed tomography scan revealed longitudinal perforation.The procedure was completed with this device.After the procedure, inflammation was found at the perforated site.Based upon the physician's assessment it is unknown if the peg tube or the endoscope contributed to the perforation.Patient was given antibiotic (unknown name) as treatment.Reportedly, the patient at convalescent stage now.

Manufacturer Narrative

Additional information: b5 block e1 (initial reporter city): (b)(6).Block d4, h4: the complainant was unable to report the upn and batch/lot number; manufacture date, and expiration date are unknown.Block h6 (patient codes): patient code 1987 captures the reportable event of patient having perforation.Block h6 (evaluation conclusion codes): the complainant indicated that the device will not be returned for evaluation as it is implanted in the patient; 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 was used during a percutaneous endoscopic gastrostomy (peg) placement procedure (b)(6) 2019 according to the complainant, after placement of the peg, blood adhered in the esophagus as shown in the endoscope.A computed tomography scan revealed longitudinal perforation.The procedure was completed with this device.After the procedure, inflammation was found at the perforated site.Based upon the physician's assessment it is unknown if the peg tube or the endoscope contributed to the perforation.Patient was given antibiotic (unknown name) as treatment.Reportedly, the patient at convalescent stage now.Additional information received on (b)(6) 2020: the tube feeding was stopped for the fasting therapy (fast cure).

• 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: 9633849
• MDR Text Key: 176569067
• Report Number: 3005099803-2020-00165
• Device Sequence Number: 1
• Product Code: KNT
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 03/11/2020

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?: No
• Device Operator: Health Professional
• Device Model Number: M00566521
• Device Catalogue Number: 6652
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/07/2020
• Initial Date FDA Received: 01/27/2020
• Supplement Dates Manufacturer Received: 02/19/2020
• Supplement Dates FDA Received: 03/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other