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

Model Number	M00558330
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/01/2019
Type of Reportable Event	Malfunction
Additional 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 or Problem 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.
Additional 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 or Problem 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
• Common Device Name: DILATOR, ESOPHAGEAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 9662247
• Report Number: 3005099803-2020-00174
• Device Sequence Number: 19528979
• Product Code: KNQ
• UDI-Device Identifier: 08714729201984
• UDI-Public: 08714729201984
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K971320
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/13/2020

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
• Operator of Device: 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
• Initial Date Received by Manufacturer: 01/07/2020
• Supplement Date Received by Manufacturer: 03/19/2020
• Initial Report FDA Received Date: 02/03/2020
• Supplement Report FDA Received Date: 04/13/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 58 YR
• Patient Weight: 50