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

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

Patient Problem Perforation (2001)

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 g2: literature: tenlik, i (2022), pneumatic dilation in geriatric achalasia patients (2022) 19:508-515.Doi: 10.5152/tjg.2023.22178.Block h6: imdrf patient code e2114 captures the reportable event of perforation.

Event Description

Boston scientific corporation became aware of multiple events through the article "pneumatic dilation in geriatric achalasia patients" written by ilyas tenlik, et al.According to the literature, between 1995 and 2020 achalasia patients (over the age of 65 and those under the age of 65 as the control group) received pneumatic dilations with rigiflex ii balloons (30, 35 and 40 mm in diameter) and the effectiveness was evaluated.The study included 143 achalasia patients over 65 years of age and 150 achalasia patients under 65 years of age.Mean age of geriatric patients was 72.7 +/- 5.92 (65-90), and 50.3% of them were male.Follow-up was conducted for a mean of 64.52 +/- 38.73 months.Mean age of nongeriatric patients was 43.07 +/- 11.69 (18-63), and 58.7% of them were male.A gradual dilation method was used in the patients and initial dilation was performed with a 30 mm balloon inflated with approximately 10 psi.After 4-6 weeks of dilation, patients were evaluated, and gradual balloon diameter increase (35 or 40mm balloon) treatments were continued if necessary.Balloon related adverse events were observed in two patients.Perforation developed in two of the 293 patients in total.One patient underwent surgical treatment due to the perforation that developed after the first balloon dilation.

• 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: 17032221
• MDR Text Key: 316298564
• Report Number: 3005099803-2023-02848
• Device Sequence Number: 1
• Product Code: PID
• Combination Product (y/n): N
• Reporter Country Code: TU
• 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