MAUDE Adverse Event Report: BOSTON SCIENTIFIC - COSTA RICA (COYOL) CRE PRO GI; DILATOR, ESOPHAGEAL

Model Number M00558770

Device Problem Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The complainant was unable to provide the lot number.Therefore, the manufacture and expiration dates are unknown.It was reported the device was not used past its expiry date.Device code relates to problem code for the investigation result of exit marker bunched up.A visual examination of the complaint device revealed that the catheter was cut and only the distal section of the device was received.The exit marker was noted to be bunched up.Functional analysis could not be performed due to the condition of the device.Based on the condition of the returned device, the noted defects likely occurred due to anatomical or procedural factors which limited the performance of the balloon.Therefore, the most probable root cause is operational context.

Event Description

It was reported to boston scientific corporation that a cre pro gi wireguided dilatation balloon was used in the upper gastrointestinal tract during a procedure performed on an unknown date.According to the complainant, during the procedure, there was a problem noted with the sheath, so the procedure was discontinued.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.Attempts to obtain additional information regarding this event have been unsuccessful to date.Should additional relevant details become available, a supplemental report will be submitted.Investigation results revealed that the exit marker was bunched up; therefore, this is now an mdr reportable event.

• Brand Name: CRE PRO GI
• 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: 7660780
• MDR Text Key: 113187081
• Report Number: 3005099803-2018-02197
• Device Sequence Number: 1
• Product Code: KNQ
• Combination Product (y/n): N
• PMA/PMN Number: K971320
• 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: 06/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/03/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M00558770
• Device Catalogue Number: 5877
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/11/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/28/2018
• Was Device Evaluated by Manufacturer?: Yes
• 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