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

Model Number M00558330

Device Problem Material Integrity Problem (2978)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/01/2019

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 fixed wire dilatation balloon was used in the duodenal papilla during an esophagogastroduodenoscopy (egd) procedure performed on (b)(6) 2019.According to the complainant, during the procedure, the balloon was noted to be damaged during the inflation in the esophagus.The procedure was completed with another cre fixed wire dilatation balloon.There were no patient complications reported as a result of this event.The patient condition at the conclusion of the procedure was reported to be stable.

Manufacturer Narrative

Block h6: problem code 2978 captures the reportable issue of balloon damaged.Block h10: investigation results: a visual examination of the returned complaint device revealed that the balloon did not have any visual defects and looked normal.The catheter of the device was carefully inspected and no damages were found.Functional evaluation was performed by attaching the device into an alliance inflation system, the balloon was inflated and deflated completely without problem; there were no leaks, holes, pinholes noted and the balloon was able to hold the pressure.Additionally, there was no occlusion noted on the device.The returned device showed no evidence of either the alleged issue or any other defect which could have contributed to the event (visual, physical and performance testing).Therefore the root cause for this complaint is no problem detected.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 fixed wire dilatation balloon was used in the duodenal papilla during an esophagogastroduodenoscopy (egd) procedure performed on (b)(6) 2019.According to the complainant, during the procedure, the balloon was noted to be damaged during the inflation in the esophagus.The procedure was completed with another cre fixed wire dilatation balloon.There were no patient complications reported as a result of this event.The patient condition at the conclusion of the procedure was reported to be stable.

• Brand Name: CRE FIXED WIRE
• Type of Device: DILATOR, ESOPHAGEAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 9662247
• MDR Text Key: 189993945
• Report Number: 3005099803-2020-00174
• Device Sequence Number: 1
• Product Code: KNQ
• UDI-Device Identifier: 08714729201984
• UDI-Public: 08714729201984
• 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: 04/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/03/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/27/2020
• Device Model Number: M00558330
• Device Catalogue Number: 5833
• Device Lot Number: 0021921978
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/21/2020
• Date Manufacturer Received: 03/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 58 YR
• Patient Weight: 50