MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION RIGIFLEX II; DILATOR, ESOPHAGEAL

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

Patient Problems Chest Pain (1776); Perforation of Esophagus (2399)

Event Date 05/01/2023

Event Type  Injury  

Manufacturer Narrative

Block d4, h4: the complainant was unable to provide the suspect device upn and lot number.Therefore, the manufacture date and expiration date are unknown.Block e1: initial reporter facility name: the initial reporter facility name is institute of postgraduate medical education and research (ipgmer).Block g2: literature: misra, d, banerjee, a, das, kausik, das, kshaunish and dhali, kd (2022), outcome of sequential dilatation in achalasia cardia patients: a prospective cohort study (2022) 19:508-515.Doi: 10.1007/s10388-021-00902-5.Block h6: imdrf patient code e1022 captures the reportable event of perforation of the esophagus.

Event Description

Boston scientific corporation became aware of multiple events through the article "outcome of sequential dilatation in achalasia cardia patients: a prospective cohort study" written by debashis misra, et al.According to the literature, between september 2019 and june 2020, 30 mm rigiflex ii balloons were used under flouroscopic guidance across the gastro-esophageal junction and inflated to 20 psi for 60 seconds in 72 patients.There were 44 male and 28 female patients, with a median age of 41.5 years (range, 18-70).All patients were monitored clinically for any major adverse events after each dilation procedure.Clinical follow-up was performed four weeks after the initial dilation and additional pneumatic dilations were performed, if necessary, with 35 or 40 mm rigiflex ii balloons.Some patients continued follow-up until the end of the study period (june 2021).Balloon related adverse events were observed in three patients.Iatrogenic perforation was noted in two patients.One each episode occurred with 30 mm and 35 mm balloon.Both were managed surgically.Another patient required hospital admission for chest pain after dilatation with a 30 mm balloon.Subsequently, perforation was ruled out.

• Brand Name: RIGIFLEX II
• Type of Device: DILATOR, ESOPHAGEAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): TECHDEVICE CORPORATION; metro free trade zone; building 3 c; heredia ; CS
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 17032040
• MDR Text Key: 316289693
• Report Number: 3005099803-2023-02845
• Device Sequence Number: 1
• Product Code: PID
• Combination Product (y/n): N
• Reporter Country Code: IN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Literature,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/31/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/31/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/09/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention