MAUDE Adverse Event Report: BOSTON SCIENTIFIC - COSTA RICA (COYOL) CRE BALLOON DILATATION CATHETER; DILATOR, ESOPHAGEAL

Model Number UNK100

Device Problem Contamination /Decontamination Problem (2895)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/27/2018

Event Type  malfunction  

Manufacturer Narrative

The complainant was unable to provide the device upn and lot number.Therefore, the manufacture and expiration dates are unknown; however, it was reported the device was not used past its expiry date.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 cre fixed wire dilatation balloon was used during a colonic dilation procedure performed on (b)(6) 2018.According to the complainant, the balloon protective sleeve was not removed from the balloon prior to use and was accidentally left inside the scope.The scope was reprocessed and was reportedly used on eight patients before the piece was discovered inside the scope.There were no patient complications reported as a result of this event.The patient's condition after the procedure was reported to be stable.

• Brand Name: CRE BALLOON DILATATION CATHETER
• Type of Device: DILATOR, ESOPHAGEAL
• Manufacturer (Section D): BOSTON SCIENTIFIC - COSTA RICA (COYOL); 2546 first street; propark free zone; alajuela ; CS
• Manufacturer (Section G): BOSTON SCIENTIFIC - COSTA RICA (COYOL); 2546 first street; propark free zone; alajuela ; CS
• Manufacturer Contact: nancy cutino ; 100 boston scientific way; marlborough, MA 01752 ; 5086834000
• MDR Report Key: 7533326
• MDR Text Key: 108899399
• Report Number: 3005099803-2018-01596
• Device Sequence Number: 1
• Product Code: KNQ
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K971320
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 05/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/22/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UNK100
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/01/2018
• 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