MAUDE Adverse Event Report: BOSTON SCIENTIFIC - COSTA RICA (COYOL) CRE¿ WIREGUIDED; BALLOON DILATOR

Model Number M00558660

Device Problem Detachment Of Device Component (1104)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/30/2017

Event Type  Injury  

Manufacturer Narrative

Patient's exact age is unknown; however it was reported that the patient was over the age of 18.The complainant was unable to provide the lot number.Therefore, the manufacture and expiration dates are unknown.It was reported that the device was not expired.(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.(b)(4).

Event Description

It was reported to boston scientific corporation that a cre pro wireguided dilatation balloon was used in the esophagus during a gastroscopy procedure performed on (b)(6) 2017.According to the complainant, during the procedure, the black endoscopic marker crumpled and detached from the catheter.After the procedure was completed, the balloon was withdrawn from the scope.The black endoscopic marker was noted to be left inside the patient and was retrieved using a grasping forceps.The procedure was completed at this time.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.

• Brand Name: CRE¿ WIREGUIDED
• Type of Device: BALLOON DILATOR
• 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: 7135639
• MDR Text Key: 95411755
• Report Number: 3005099803-2017-03687
• Device Sequence Number: 1
• Product Code: KNQ
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: K112994
• 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: 11/30/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M00558660
• Device Catalogue Number: 5866
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/30/2017
• 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