MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. SINGLE USE 3-LUMEN EXTRACTION BALLOON V

Model Number	B-V443Q-A
Medical Device Problem Codes	Break (1069); Deflation Problem (1149)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/19/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not been returned to the service center for evaluation.Therefore, the exact cause for the reported event cannot be determined.Upon receipt of the device and evaluation, a supplemental report will be submitted.
Event or Problem Description
The service center received a report of an extraction balloon (b-v443q-a) that would not deflate, and the catheter broke during the unspecified procedure.The physician retrieved the items from the patient.It was reported there was no patient harm.It is unknown if the intended procedure was completed.
Event or Problem Description
The service center received a report of a single use 3-lumen extraction balloon v, model b-v443q-a, lot number 92 v27, that would not deflate and caused a catheter to break at the end of a procedure.The balloon and catheter were inspected prior to the procedure and observed to have no anomalies.It was reported the physician had completed a therapeutic endoscopic retrograde cholangiopancreatography (ercp), when in the process of removing the balloon, it would not delate and caused the catheter to break into two pieces inside the patient.The balloon and catheter pieces were retrieved by the physician using a snare without injury to the patient.The patient was discharged the same day.The balloon was still inflated when it was retrieved and had no holes or any damages that were visually observed.It was reported that the balloon was inflated as instructed to 15 mm, without lubrication, using the premeasured syringes included in the package.The maximum reading on the syringe is 15 mm.It is unknown if the stopcock was rotated 90 degrees counterclockwise to open and remove the syringe, to deflate the balloon.Fluoroscopy/ x-ray was used during the procedure.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide additional information, device evaluation and correction of the lot number and manufacture date.Please see the updated sections: a2, a3, a4, b5, b7, d4, d10, d11, g4, g7, h2, h3, h4, h6, and h10.The single use 3-lumenextraction balloon was returned to the service center for the evaluation of ¿the balloon would not deflate¿.The device was visually inspected in the received condition and it was noted that the distal end tip was broken, exposing the metal wires inside the outer tube.The distal end was further inspected and it was observed that the fluoro tip was missing and was not returned with the device to the service center for evaluation.The insertion portion of the balloon was inspected and found to have a kink on the lower section of the v marking.The control section was inspected and there no external damages noted to the injection port, air feeding port, or knob.Based on the evaluation, the user¿s complaint ¿the balloon would not deflate¿ was confirmed.The cause of the reported issue was the distal end was broken, which was most likely due to excessive force attributed to mishandling.

• Brand Name: SINGLE USE 3-LUMEN EXTRACTION BALLOON V
• Common Device Name: SINGLE USE 3-LUMEN EXTRACTION BALLOON
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• MDR Report Key: 9571934
• Report Number: 8010047-2020-00856
• Device Sequence Number: 428573
• Product Code: FGE
• UDI-Device Identifier: 04953170279553
• UDI-Public: 04953170279553
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K091495
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/21/2020

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 Model Number: B-V443Q-A
• Device Lot Number: 92V 27
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/06/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 12/19/2019
• Supplement Date Received by Manufacturer: 01/15/2020
• Initial Report FDA Received Date: 01/09/2020
• Supplement Report FDA Received Date: 01/21/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SNARESPHINCTEROTOMESTENT
• Patient Age: 77 YR
• Patient Weight: 104