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 04/17/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Investigation results: a visual examination of the complaint device revealed that the exit marker was bunched in both sides of the catheter.It was also noted that the catheter was cut.Functional analysis could not be performed due to the condition of the device.This failure likely occurred due to anatomical/procedural factors which limited the performance of the balloon.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.A search of the complaint database revealed that no other complaints exist for the specified lot.

Event Description

It was reported to boston scientific corporation that a cre pro gi wireguided balloon was used during a dilatation procedure on (b)(6) 2017.According to the complainant, they were unable to remove the device out through the endoscope, so the endoscope and the device was removed from the patient.It was noted that the black exit marker bunched up.The procedure was completed with another cre pro gi wireguided balloon.There were no patient complications reported as a result of this event.

• 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: 6558560
• MDR Text Key: 74910085
• Report Number: 3005099803-2017-01296
• 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: 04/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/10/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2019
• Device Model Number: M00558830
• Device Catalogue Number: 5883
• Device Lot Number: 0020172194
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/21/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/18/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/19/2017
• 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