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 Date 07/19/2017

Event Type  malfunction  

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 the device was not used past its expiry date.(b)(4).Investigation results: a visual examination of the returned complaint device found that the exit marker was bunched up in its proximal side.A kink in the shaft was noticed.It was also noted that there were residues of liquid solution within the balloon.Based on the condition of the returned device, the noted defect likely occurred due to handling of the device or portion of the device without direct patient contact either during shipping, unpacking or preparation of the device for the procedure.Therefore, the most probable root cause of this complaint is handling damage.

Event Description

It was reported to boston scientific corporation that a cre pro wireguided dilatation balloon was used in the upper gastrointestinal tract during a dilatation procedure performed on (b)(6) 2017.According to the complainant, during the procedure, the catheter was unable to be inserted through the endoscope channel.The procedure was completed with another cre pro balloon.There were no patient complications reported as a result of this event.Investigation results revealed that the exit marker was buched up in its proximal side; 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: 6827604
• MDR Text Key: 83893548
• Report Number: 3005099803-2017-02502
• 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: 08/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/29/2017
• 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: 07/24/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/08/2017
• 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