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

Model Number M00554510

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

Patient Problems Perforation (2001); No Code Available (3191)

Event Date 12/13/2019

Event Type  Injury  

Manufacturer Narrative

Patient's exact age is unknown; however, it was reported that the patient was over the age of 18.(b)(4).According to the complainant, the suspect device has been disposed and is not available for return.If any further relevant information is received, a supplemental mdr will be filed.

Event Description

It was reported to boston scientific corporation that a rigiflex ii dilatation balloon was used in the esophagus during an esophagogastroduodenoscopy (edg) with dilatation procedure performed on (b)(6) 2019.According to the complainant, after the dilatation, it was noted that the esophagus had been perforated.The patient was then transferred to (b)(6) where an emergent surgery was performed by a cardio-thoracic surgeon.Following the treatment, the patient condition was reported to be stable.It was noted that there was no malfunction of the rigiflex ii dilatation balloon, and per the physician's assessment, the cause of the perforation was the anatomy.Boston scientific has been unable to obtain additional information regarding the event to date, despite good faith efforts.

• 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; 400m este de holcim; san rafael alajuela ; CS
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 9564068
• MDR Text Key: 174152564
• Report Number: 3005099803-2019-06443
• Device Sequence Number: 1
• Product Code: PID
• UDI-Device Identifier: 08714729719113
• UDI-Public: 08714729719113
• Combination Product (y/n): N
• PMA/PMN Number: K050232
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/08/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/13/2020
• Device Model Number: M00554510
• Device Catalogue Number: 5451
• Device Lot Number: C021175
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/13/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/13/2019
• 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