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

Model Number M00558830

Device Problem Material Twisted/Bent (2981)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/16/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device has not been received for analysis.Upon receipt and 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 during a procedure performed on (b)(6) 2020.According to the complainant, during the procedure, it was noted that deflation was performed after the dilatation.After being retracted in the endoscope, the stylet could not be advanced again due to the tip part of the balloon was kinked.The procedure was completed another cre pro gi wireguided dilatation balloon.There were no patient complications reported as a result of this event.

Manufacturer Narrative

Block h6: problem code 2981 captures the reportable event of balloon tip bent.Block h10: investigation result: visual examination of the returned complaint device found the balloon did not show visual defects.It was noted that the guidewire and the internal lumen on the balloon portion were kinked, thereby confirming the reported event.No damage was found on the catheter of the device.This failure is likely due to factors encountered during the procedure, such as handling or manipulation during the initial use or during the procedure that could have affected its 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 (b)(6) 2020.According to the complainant, during the procedure, it was noted that deflation was performed after the dilatation.After being retracted in the endoscope, the stylet could not be advanced again due to the tip part of the balloon was kinked.The procedure was completed another cre pro gi wireguided dilatation 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 CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 10271623
• MDR Text Key: 199696175
• Report Number: 3005099803-2020-02674
• 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
• Type of Report: Initial,Followup
• Report Date: 10/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/14/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/02/2023
• Device Model Number: M00558830
• Device Catalogue Number: 5883
• Device Lot Number: 0025305825
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/02/2020
• Date Manufacturer Received: 09/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1