MAUDE Adverse Event Report: BOSTON SCIENTIFIC - CORK CRE PRO GI; DILATOR, ESOPHAGEAL

Model Number M00558830

Device Problem Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/17/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Investigation results visual examination of the returned complaint device confirmed that the black exit marker was detached and was not returned with the device.It was also noted that the catheter was stretched in two different sections.Based on the condition of the returned device, the noted defects likely occurred due to anatomical or procedural factors encountered during the procedure.Therefore, the most probable root cause is operational context.A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly and performance specifications.

Event Description

Note: this report pertains to one of two cre pro wireguided dilatation balloons used during the same procedure.Manufacturer report# 3005099803-2018-00196 pertains to the first device, and manufacturer report# 3005099803-2018-00197 pertains to the second device.It was reported to boston scientific corporation that two cre pro wireguided dilatation balloons were used in a procedure performed on (b)(6) 2018.According to the complainant, during the procedure, while removing the device from the scope, the black exit marker bunched up and detached from the rest of the device.No piece of the device detached inside the patient.On the second balloon, the exit marker bunched up but remained on the catheter.The procedure was completed with another cre pro wireguided dilatation balloon.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 - CORK; business and technology park; model farm road; cork ; EI
• Manufacturer (Section G): BOSTON SCIENTIFIC - CORK; business and technology park; model farm road; cork ; EI
• Manufacturer Contact: nancy cutino ; 100 boston scientific way; marlborough, MA 01752 ; 5086834000
• MDR Report Key: 7261040
• MDR Text Key: 99904306
• Report Number: 3005099803-2018-00197
• 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: 01/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/03/2020
• Device Model Number: M00558830
• Device Catalogue Number: 5883
• Device Lot Number: 21336918
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/22/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/17/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/03/2017
• 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