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

Model Number M00558500

Device Problem Deflation Problem (1149)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/30/2020

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 wireguided dilatation balloon was used in the esophagus during an esophagogastroduodenoscopy (egd) procedure performed on (b)(6) 2020.According to the complainant, during the procedure, the balloon did not completely deflate.The device was removed from the patient by removing the entire scope.The procedure was completed at this time.There were no patient complications reported as a result of this event.

Event Description

It was reported to boston scientific corporation that a cre wireguided dilatation balloon was used in the esophagus during an esophagogastroduodenoscopy (egd) procedure performed on (b)(6) 2020.According to the complainant, during the procedure, the balloon did not completely deflate.The device was removed from the patient by removing the entire scope.The procedure was completed at this time.There were no patient complications reported as a result of this event.

Manufacturer Narrative

Block h6: problem code a1401 captures the reportable event of balloon failed to deflate.Block h10: investigation result: visual examination of the returned complaint device found that the catheter was detached in two sections.Additionally, the catheter was stretched close to the detached section and was partially torn in the lumen of the wire side.The wire was kinked on the distal tip.Functional evaluation was unable to be performed due to the condition of the device, and therefore the reported issue cannot be tested.Based on the information provided, the stretching of the catheter likely occurred as a consequence of the device interaction with the scope and stricture and the resulting force applied on the device.The stretching of the catheter then likely led to the catheter detachment.However, the most probable cause of the reported issue of balloon deflation failure is unable to be determined due to the device condition when returned.Therefore, the most probable root cause cannot be established.A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly and performance specifications.

• Brand Name: CRE WIREGUIDED
• Type of Device: DILATOR, ESOPHAGEAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 11206866
• MDR Text Key: 227949799
• Report Number: 3005099803-2021-00146
• Device Sequence Number: 1
• Product Code: KNQ
• UDI-Device Identifier: 08714729339434
• UDI-Public: 08714729339434
• Combination Product (y/n): N
• PMA/PMN Number: K110833
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 03/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/18/2023
• Device Model Number: M00558500
• Device Catalogue Number: 5850
• Device Lot Number: 0026031445
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/15/2021
• Initial Date Manufacturer Received: 12/30/2020
• Initial Date FDA Received: 01/21/2021
• Supplement Dates Manufacturer Received: 02/23/2021
• Supplement Dates FDA Received: 03/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1