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

Model Number M00558760

Device Problem Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/08/2017

Event Type  malfunction  

Manufacturer Narrative

The complainant was unable to provide the device lot number.Therefore, the manufacture and expiration dates are unknown.(b)(4).Although the suspect device has been received, the evaluation has not been completed.Therefore, the cause of the reported malfunction has not been determined.Upon completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental mdr will be filed.

Event Description

It was reported to boston scientific corporation that a cre pro gi wireguided dilatation balloon was used in the esophagus during an esophageal stenosis dilation procedure performed on (b)(6) 2017.According to the complainant, after dilation, upon removing the device from the endoscope the balloon and exit marker got caught in the endoscope and could not be removed.The exit marker was noted to have bunched up.Reportedly, the device was removed and retrieved by cutting the catheter on the distal tip side of the endoscope.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.

Manufacturer Narrative

Investigation results: a visual examination of the complaint device revealed that the catheter was cut.The exit marker was noted to be bunched up along its length.This failure is likely due to anatomical/procedural factors encountered during the procedure limited the performance of the device.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 esophagus during an esophageal stenosis dilation procedure performed on (b)(6) 2017.According to the complainant, after dilation, upon removing the device from the endoscope the balloon and exit marker got caught in the endoscope and could not be removed.The exit marker was noted to have bunched up.Reportedly, the device was removed and retrieved by cutting the catheter on the distal tip side of the endoscope.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 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: 6681524
• MDR Text Key: 78958908
• Report Number: 3005099803-2017-01979
• 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,Followup
• Report Date: 06/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/30/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M00558760
• Device Catalogue Number: 5876
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/22/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/07/2017
• 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