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

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

Patient Problem Insufficient Information (4580)

Event Date 01/01/2004

Event Type  Injury  

Manufacturer Narrative

Block b3: the procedure occurred in 2004.However, the exact event onset date is unknown.The provided event date of (b)(6) 2004 was chosen as a best estimate based on the year when the procedure was performed.Blocks d4, h4: the complainant was unable to provide the suspect device upn and lot number; therefore, the lot expiration and device manufacture dates are unknown.Block h6: impact code f12 has been used for an unspecified personal injury and transmural injection procedure performed.Block h7: in october 2005, boston scientific issued a recall of all enteryx procedure kits and enteryx injector single packs from commercial distribution.

Event Description

A patient who had had an enteryx injection procedure in 2004 contacted boston scientific corporation on june 2, 2023, to inquire if surgical staples were used in the procedure, as "she is currently experiencing medical issues, which her doctors believe are due to staples in her body." surgical staples are not indicated for this injection procedure.Subsequent follow up with the patient revealed that she had had an unrelated issue with her procedure in 2004: she reported to boston scientific corporation that during the implant procedure in 2004 "the doctor that did the procedure did a transmural injection and the polymer is on the outside of my esophagus." procedural information, and the patient's condition following the procedure in 2004, were not made available.Note: in october 2005, boston scientific removed all enteryx procedure kits and enteryx injector single packs from commercial distribution.

• Brand Name: ENTERYX PROCEDURE KIT
• Type of Device: AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 780 brookside drive; spencer IN 47460
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 17240483
• MDR Text Key: 318231415
• Report Number: 3005099803-2023-03572
• Device Sequence Number: 1
• Product Code: LNM
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 06/30/2023

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
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/02/2023
• Initial Date FDA Received: 06/30/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Removal/Correction Number: 90211124-FA
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Female