MAUDE Adverse Event Report: BOSTON SCIENTIFIC - MARLBOROUGH RIGIFLEX II ACHALASIA BALLOON DILATOR; DILATOR, ESOPHAGEAL

Model Number M00554520

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Perforation (2001)

Event Date 05/09/2014

Event Type  Injury  

Event Description

It was reported to boston scientific corporation that a rigiflex balloon was used during an esophagogastroduodenoscopy (egd) procedure in the gastroesophageal junction performed on (b)(6) 2014.According to the complainant, during the procedure, the guidewire introducer broke and lodged inside the endoscope.The endoscope was removed from the patient with the broken fragment; nothing detached inside the patient.The dilation procedure was completed with this device, however, a perforation in the patient¿s esophagus was noted.The perforation was treated with surgery.The patient's condition at the conclusion of the procedure was reported to be fine.

Manufacturer Narrative

(b)(4) for the reported event of guidewire introducer broke/detached.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.

• Brand Name: RIGIFLEX II ACHALASIA BALLOON DILATOR
• Type of Device: DILATOR, ESOPHAGEAL
• Manufacturer (Section D): BOSTON SCIENTIFIC - MARLBOROUGH; 100 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): TECHDEVICE CORPORATION; 650 pleasant street; watertown MA 02472
• Manufacturer Contact: ingrid matte ; 100 boston scientific way; marlborough, MA 01752 ; 5086834000
• MDR Report Key: 3853663
• MDR Text Key: 4657348
• Report Number: 3005099803-2014-02117
• Device Sequence Number: 1
• Product Code: KNQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K050232
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/13/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/06/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 12/31/2014
• Device Model Number: M00554520
• Device Catalogue Number: 5452
• Device Lot Number: 0000103338
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/13/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/16/2013
• 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