MAUDE Adverse Event Report: BOSTON SCIENTIFIC - MARLBOROUGH ENTERYX PROCEDURE KIT; AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE

Model Number UNK121

Device Problem Migration or Expulsion of Device (1395)

Patient Problems Dysphagia/ Odynophagia (1815); Pain (1994)

Event Type  Injury  

Manufacturer Narrative

The complainant was unable to provide the device model, catalog number, or lot number.Therefore, the manufacture and expiration dates are unknown.The upn is unknown, therefore both applicable recall numbers have been listed.The device will not be returned, as this device is an implantable material and remains implanted in the patient.Note: this product was removed from the global market in september 2005.Boston scientific corporation no longer produces the reported product.

Event Description

It was reported to boston scientific corporation that enteryx was used during an enteryx implant procedure performed on an unknown date in (b)(6) 2005.Prior to the enteryx procedure, the patient had severe gerd and was adversely affected by gerd medications.The gastroenterologist initially suggested fundoplication, but the patient opted against it.Two months post enteryx implant procedure, the patient铠gerd symptoms were resolved.The patient did not have further gastrointestinal issues until approximately three years ago in the form of chest pain.According to the complainant, a cat scan following that event (but on an unknown date) revealed that the enteryx material had migrated; no medical treatment was performed.The pain subsided until about two weeks prior to the complaint notification, when the patient began experiencing severe pain in the center of her chest, some dysphagia, an inability to lay on her right side, and an inability to "take a deep breath".The patient is not currently receiving medical treatment or therapy for these symptoms, but plans to follow up with a gastroenterologist to discuss treatment options.

• Brand Name: ENTERYX PROCEDURE KIT
• Type of Device: AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE
• Manufacturer (Section D): BOSTON SCIENTIFIC - MARLBOROUGH; 100 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC - MARLBOROUGH; 100 boston scientific way; marlborough MA 01752
• Manufacturer Contact: nancy cutino ; 100 boston scientific way; marlborough, MA 01752 ; 5086834000
• MDR Report Key: 5348628
• MDR Text Key: 35190924
• Report Number: 3005099803-2016-00024
• Device Sequence Number: 1
• Product Code: LNM
• Combination Product (y/n): N
• PMA/PMN Number: P020006
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Reporter Occupation: Patient
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 12/18/2015

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 Model Number: UNK121
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/18/2015
• Initial Date FDA Received: 01/06/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Removal/Correction Number: Z-0040-6 AND Z-0041-6
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 58 YR