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

Model Number M00558770

Device Problem Material Puncture/Hole (1504)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/01/2020

Event Type  malfunction  

Manufacturer Narrative

Date of event: date of event was approximated to (b)(6) 2020 as no event date was reported.(b)(6).(b)(4).Investigation results: visual examination of the returned complaint device found the balloon did not show visual defects and looked normal.Functional analysis was performed, and the balloon was inflated without a problem; however, the balloon would not hold pressure due to a pinhole in the distal section on the body of the balloon.This failure is likely due to factors encountered during the procedure, such as handling of the device, the technique used by the physician, the interaction with the scope, and normal procedural difficulties encountered during the procedure, that could have affected device performance and its intended purpose.Therefore, the most probable root cause is adverse event related to procedure.A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly and performance specifications.

Event Description

It was reported to boston scientific corporation that a cre pro gi wireguided dilatation balloon was used during a procedure performed on an unknown date.According to the complainant, during the procedure, it was noticed that the balloon had a hole.The procedure was completed another cre pro gi wireguided dilatation balloon.There were no patient complications reported as a result of this event.Investigation results revealed that the balloon had a pinhole; therefore, this is now an mdr reportable event.

• Brand Name: CRE PRO GI
• Type of Device: DILATOR, ESOPHAGEAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORK LIMITED; cork business technology park; model farm road; cork ; EI
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 10277366
• MDR Text Key: 199721874
• Report Number: 3005099803-2020-02696
• Device Sequence Number: 1
• Product Code: KNQ
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 07/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/15/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/14/2023
• Device Model Number: M00558770
• Device Catalogue Number: 5877
• Device Lot Number: 0025210826
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/11/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/19/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/14/2020
• 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