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

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

Patient Problems Pneumothorax (2012); Perforation of Esophagus (2399)

Event Date 05/01/2023

Event Type  Injury  

Event Description

Boston scientific corporation became aware of multiple events through the article "endoscopic clipping of a complicated esophageal perforation following pneumatic dilation for achalasia: a case study and literature review" written by mohammad minakari, et al.On (b)(6) 2018, the patient presented and was diagnosed with achalasia based on typical findings in his history of illness, follow-up upper gastrointestinal endoscopy, and upper gastrointestinal x-ray series.He was therefore, admitted and prescribed with an only-clear-liquid preparation diet, before undergoing pneumatic balloon dilation (pbd) 2 days later.The pbd procedure was initiated by sedating the patient with midazolam (15 mcg/kg, iv) and propofol (2 mg/kg, iv).His vital signs were being monitored throughout the procedure by the team of anesthesiologists and gastroenterologists who were performing it.Under direct endoscopic vision, the scope was passed to the stomach and second portion of duodenum, facilitating the placement of a guide wire in the gastric antrum.A 30 mm rigiflex ii balloon was, thereafter, passed into the esophagus on the guide wire.After being placed in the proper site under direct endoscopic vision, the balloon dilator was inflated for 60 seconds with 10 psi pressure per protocol.It was then successfully deflated and withdrawn.Immediate endoscopic inspection after dilation revealed what appeared to be a 3 cm linear, deep mucosal tearing at the left lateral side of the lower esophagus.Closer inspection revealed that it was a complete transmural tear of the esophageal wall.Transmural esophageal perforation was immediately diagnosed and confirmed, after the patient developed subcutaneous emphysema at the anterolateral sides of his chest and neck.Although large, the tear was linear and seemed amenable to endoscopic repair; hence, the team decided to attempt for an endoscopic closure of the tear using endo-clips.First, the distal margin of the tear was closed to prevent any further widening, and then, it was closed in an upward direction.A total of six clips were used to close the entire tear.After that, a nasogastric tube was placed for the patient under endoscopic guide, and the procedure was terminated.The patient started to show symptoms of respiratory failure; therefore, he was intubated after the procedure, was transferred to intensive care unit (icu), and was prescribed with intravenous (iv) fluids and antibiotics.There, he had subcutaneous emphysema in his chest, neck, and face.A subsequent chest radiograph 4 hours after the procedure revealed left pneumothorax, which was managed with a chest tube placed in the fifth intercostal space.He was then put on mechanical ventilation while being closely observed in the icu.24 hours later, he regained spontaneous ventilation.He was therefore, extubated, and did not show any sign of respiratory distress thereafter.After 6 days of parenteral diet upper gastrointestinal x-ray series and computer tomography studies were performed, revealing no leakage.On day eight post-pbd, after a follow- up chest radiograph confirmed complete expansion of the left lung, the chest tube was removed and replaced with a petroleum sterile gauze dressing, and the patient was discharged.In a follow-up visit on (b)(6) 2018 (3 months post-pbd), the patient reported complete resolution of his achalasia symptoms, without any further sequelae.

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: minakari, m and sedaghat, n (2022) endoscopic clipping of a complicated esophageal perforation following pneumatic dilation for achalasia: a case study and literature review.Clin case rep.2022;10:e06620.Pg.1-5.Https://doi.Org/10.1002/ccr3.6620.Block h6: imdrf patient code e0734 captures the reportable event of pneumothorax.Imdrf patient code e1022 captures the reportable event of perforation in the esophagus.

Event Description

Boston scientific corporation became aware of multiple events through the article "endoscopic clipping of a complicated esophageal perforation following pneumatic dilation for achalasia: a case study and literature review" written by mohammad minakari, et al.In (b)(6) 2018, the patient presented and was diagnosed with achalasia based on typical findings in his history of illness, follow-up upper gastrointestinal endoscopy, and upper gastrointestinal x-ray series.He was therefore, admitted and prescribed with an only-clear-liquid preparation diet, before undergoing pneumatic balloon dilation (pbd) 2 days later.The pbd procedure was initiated by sedating the patient with midazolam (15 mcg/kg, iv) and propofol (2 mg/kg, iv).His vital signs were being monitored throughout the procedure by the team of anesthesiologists and gastroenterologists who were performing it.Under direct endoscopic vision, the scope was passed to the stomach and second portion of duodenum, facilitating the placement of a guide wire in the gastric antrum.A 30 mm rigiflex ii balloon was, thereafter, passed into the esophagus on the guide wire.After being placed in the proper site under direct endoscopic vision, the balloon dilator was inflated for 60 seconds with 10 psi pressure per protocol.It was then successfully deflated and withdrawn.Immediate endoscopic inspection after dilation revealed what appeared to be a 3 cm linear, deep mucosal tearing at the left lateral side of the lower esophagus.Closer inspection revealed that it was a complete transmural tear of the esophageal wall.Transmural esophageal perforation was immediately diagnosed and confirmed, after the patient developed subcutaneous emphysema at the anterolateral sides of his chest and neck.Although large, the tear was linear and seemed amenable to endoscopic repair; hence, the team decided to attempt for an endoscopic closure of the tear using endo-clips.First, the distal margin of the tear was closed to prevent any further widening, and then, it was closed in an upward direction.A total of six clips were used to close the entire tear.After that, a nasogastric tube was placed for the patient under endoscopic guide, and the procedure was terminated.The patient started to show symptoms of respiratory failure; therefore, he was intubated after the procedure, was transferred to intensive care unit (icu), and was prescribed with intravenous (iv) fluids and antibiotics.There, he had subcutaneous emphysema in his chest, neck, and face.A subsequent chest radiograph 4 hours after the procedure revealed left pneumothorax, which was managed with a chest tube placed in the fifth intercostal space.He was then put on mechanical ventilation while being closely observed in the icu.24 hours later, he regained spontaneous ventilation.He was therefore, extubated, and did not show any sign of respiratory distress thereafter.After 6 days of parenteral diet upper gastrointestinal x-ray series and computer tomography studies were performed, revealing no leakage.On day eight post-pbd, after a follow- up chest radiograph confirmed complete expansion of the left lung, the chest tube was removed and replaced with a petroleum sterile gauze dressing, and the patient was discharged.In a follow-up visit in july 2018 (3 months post-pbd), the patient reported complete resolution of his achalasia symptoms, without any further sequelae.

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: minakari, m and sedaghat, n (2022) endoscopic clipping of a complicated esophageal perforation following pneumatic dilation for achalasia: a case study and literature review.Clin case rep.2022;10:e06620.Pg.1-5.Https://doi.Org/10.1002/ccr3.6620.Block h2: additional information: block d7a (sud reprocessed and reused), block e1 (initial reporter address 1 and initial reporter zip/post code) and block h8 (usage of device) block h6: imdrf patient code e0734 captures the reportable event of pneumothorax.Imdrf patient code e1022 captures the reportable event of perforation in the esophagus.

• 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: 17041575
• MDR Text Key: 316390626
• Report Number: 3005099803-2023-02864
• Device Sequence Number: 1
• Product Code: PID
• Combination Product (y/n): N
• Reporter Country Code: IR
• 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,Followup
• Report Date: 06/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/01/2023
• 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: 06/04/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 59 YR
• Patient Sex: Male