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

Model Number M00558500

Device Problems Deflation Problem (1149); Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/02/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Although the suspect device has been received, the evaluation has not been completed.Therefore, the cause of the reported malfunction has not been determined.Upon 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 would not deflate completely.It was also noticed that the guidewire was bent.The procedure was completed with another cre wireguided dilatation balloon.There have been no patient complications reported as a result of this event.The patient condition at the conclusion of the procedure was reported to be fine.

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 would not deflate completely.It was also noticed that the guidewire was bent.The procedure was completed with another cre wireguided dilatation balloon.There have been no patient complications reported as a result of this event.The patient condition at the conclusion of the procedure was reported to be fine.

Manufacturer Narrative

Block h6: problem code 1149 captures the reportable event of balloon failed to deflate.Block h10: investigation results a visual examination of the returned complaint device revealed that the balloon did not have any visual defects and was in a good condition.The catheter of the device was carefully inspected and no damages were found.It was noted that the guidewire was kinked.Functional evaluation was performed by attaching the device into an alliance inflation system, the balloon was inflated without problem; there were no leaks, holes, pinholes noted and the balloon was able to hold the pressure.Additionally, the balloon was able to deflate successfully.This failure is likely due to factors or conditions related to the procedure that could have affected its performance and its intended purpose, such as the technique used by the physician during the procedure, the amount of strength applied by the customer during the movement of the guidewire and/or the interaction between the scope and the balloon.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.

• 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: 9695132
• MDR Text Key: 190362239
• Report Number: 3005099803-2020-00272
• 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: 03/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/11/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/18/2022
• Device Model Number: M00558500
• Device Catalogue Number: 5850
• Device Lot Number: 0024283723
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/31/2020
• Date Manufacturer Received: 02/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 71 YR