MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ENDOVIVE JEJUNAL FEEDING TUBE; TUBE, FEEDING

Model Number	M00566320
Medical Device Problem Codes	Leak/Splash (1354); Loose or Intermittent Connection (1371); Migration (4003)
Health Effect - Clinical Code	Pain (1994)
Date of Event	11/28/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown at this time.(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 medwatch will be filed.
Event or Problem Description
It was reported to boston scientific corporation that an endovive three-port through the peg jejunal tube was used during a jejunal feeding tube replacement procedure performed on (b)(6) 2018.According to the complainant, the placement of the tube went well.After the sedation subsided, the patient stood up ready to go home as the procedure was already completed, it was noticed that gastric juices and bile from the patient leaked excessively from the port of the jejunal tube.It was found that the ports on the feeding tube where the food is delivered through a syringe was described as oval shape, instead of being round.The port could not be closed due to the oval shape of the port.The peg tube was not defective, it was only the jejunal tube.Also, the packaging was not damaged.It was just the product inside the package that appeared distorted.The patient also experienced stomach distension and abdominal pain which was described as very painful.Reportedly, the patient had gastroparesis  and vomited which caused the jejunal tube  to migrate up.The patient ended up pulling the entire tube out of her mouth.With her condition and with what happened to her jejunal tube, the patient was not able to receive food for 2 days.On (b)(6) 2018, the patient came back and the jejunal tube was replaced with a non bsc jejunal tube.

• Brand Name: ENDOVIVE JEJUNAL FEEDING TUBE
• Common Device Name: TUBE, FEEDING
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 8187166
• Report Number: 3005099803-2018-62098
• Device Sequence Number: 1406274
• Product Code: KNT
• UDI-Device Identifier: 08714729786313
• UDI-Public: 08714729786313
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K091340
• 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
• Report Date (Section B): 12/20/2018

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 Model Number: M00566320
• Device Catalogue Number: 6632
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/29/2018
• Initial Report FDA Received Date: 12/20/2018
• 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: Other