BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DISPOSABLE BALLOON CATHETER

    MDR report key: 11999855 · Received June 15, 2021

    Report

    Report Number
    8010047-2021-07553
    Event Type
    Injury
    Date Received
    June 15, 2021
    Date of Event
    May 19, 2021
    Report Date
    July 28, 2022
    Manufacturer
    AOMORI OLYMPUS CO., LTD.
    Product Code
    EOQ
    UDI-DI
    04953170047398
    PMA / PMN Number
    K962901
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED TO CORRECT THE MANUFACTURER NAME AND ADDRESS IN D3 AND G1. IN ADDITION, THIS REPORT IS TO CORRECT THE INITIAL AND SUPPLEMENTAL 01 REPORT MFR. REPORTING REGISTRATION NUMBER TO (B)(4).

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING UPDATED TO PROVIDE INVESTIGATION FINDINGS AND CORRECTED DATA. CORRECTED DATA IS REPORTED IN D9. NEW INFORMATION IS REPORTED IN D8, H6, AND H10. D9: AFTER REPORTING THE DEVICE WAS AVAILABLE FOR EVALUATION, THE CUSTOMER LATER STATED IT HAS BEEN DISCARDED AND COULD NOT BE RETURNED. THE DEVICE HISTORY RECORD (DHR) FOR THE COMPLAINT DEVICE HAS BEEN REVIEWED AND IT IS CONFIRMED THAT THE DEVICE MET ALL DESIGN AND QUALITY SPECIFICATION WHEN IT WAS SHIPPED. THE INSTRUCTIONS FOR USE (IFU) SHIPPED WITH THE DEVICE PROVIDES THE USER THE FOLLOWING INFORMATION RELATED TO THE REPORTED EVENT: BEFORE USE, PREPARE AND INSPECT THE INSTRUMENT AS INSTRUCTED BELOW. INSPECT OTHER EQUIPMENT TO BE USED WITH THE INSTRUMENT AS INSTRUCTED IN THEIR RESPECTIVE INSTRUCTION MANUALS. SHOULD ANY IRREGULARITY BE OBSERVED, DO NOT USE THE INSTRUMENT; CONTACT OLYMPUS. DAMAGE OR IRREGULARITY MAY COMPROMISE PATIENT OR USER SAFETY, SUCH AS AN INFECTION CONTROL RISK, TISSUE IRRITATION, PUNCTURES, BLEEDING OR MUCOUS MEMBRANE DAMAGE, AND MAY RESULT IN MORE SEVERE EQUIPMENT DAMAGE. DO NOT COIL THE INSERTION PORTION WITH A DIAMETER OF LESS THAN 15 CM. THIS COULD DAMAGE THE INSERTION PORTION. DO NOT INSERT THE INSTRUMENT INTO THE ENDOSCOPE UNLESS YOU HAVE A CLEAR ENDOSCOPIC FIELD OF VIEW. IF YOU CANNOT SEE THE DISTAL END OF THE INSERTION PORTION IN THE ENDOSCOPIC FIELD OF VIEW OR IN THE X-RAY IMAGES, DO NOT USE IT. THIS COULD CAUSE PATIENT INJURY, SUCH AS PUNCTURES, BLEEDING, OR MUCOUS MEMBRANE DAMAGE. IT MAY ALSO DAMAGE THE ENDOSCOPE AND/OR INSTRUMENT. DO NOT ANGULATE THE BENDING SECTION OF THE ENDOSCOPE (OR OPERATE THE FORCEPS ELEVATOR, IF APPLICABLE) ABRUPTLY WHILE THE DISTAL END OF THE INSERTION PORTION IS EXTENDED FROM THE DISTAL END OF THE ENDOSCOPE. THIS COULD CAUSE PATIENT INJURY, SUCH AS PUNCTURES, BLEEDING, OR MUCOUS MEMBRANE DAMAGE. .DO NOT FORCE THE DISTAL END OF THE INSERTION PORTION AGAINST BODY CAVITY TISSUE. THIS COULD CAUSE PATIENT INJURY, SUCH AS PUNCTURES, BLEEDING, OR MUCOUS MEMBRANE DAMAGE. DO NOT FORCE THE INSTRUMENT IF RESISTANCE TO INSERTION IS ENCOUNTERED. REDUCE THE ANGULATION (OR LOWER THE FORCEPS ELEVATOR, IF APPLICABLE) UNTIL THE INSTRUMENT PASSES SMOOTHLY. THIS COULD CAUSE PATIENT INJURY, SUCH AS PUNCTURES, BLEEDING, OR MUCOUS MEMBRANE DAMAGE. IT MAY ALSO DAMAGE THE ENDOSCOPE AND/OR INSTRUMENT. DO NOT ADVANCE OR EXTEND THE INSTRUMENT ABRUPTLY. THIS COULD CAUSE PATIENT INJURY, SUCH AS PUNCTURES, BLEEDING, OR MUCOUS MEMBRANE DAMAGE. IT COULD ALSO DAMAGE THE ENDOSCOPE AND/OR INSTRUMENT. WHEN INSERTING THE INSTRUMENT INTO THE ENDOSCOPE, HOLD IT CLOSE TO THE BIOPSY VALVE AND KEEP IT AS STRAIGHT AS POSSIBLE RELATIVE TO THE BIOPSY VALVE. OTHERWISE, THE INSERTION PORTION COULD BE DAMAGED. INSERT THE INSTRUMENT SLOWLY. ABRUPT INSERTION COULD DAMAGE THE ENDOSCOPE AND/OR INSTRUMENT. CONCLUSION: THE DEFINITIVE CAUSE OF THE REPORTED EVENTS COULD NOT BE ESTABLISHED. BASED ON THE INVESTIGATION FINDINGS, THE FOLLOWING ARE LIKELY POSSIBLE CAUSES OF THE PERFORATION: .THE DISTAL END OF THE INSERTION PORTION WAS FORCEFULLY PUSHED AGAINST THE BODY TISSUE. ·SINCE THE DISTAL END OF THE INSERTION PORTION WAS DEFORMED, THE TISSUE WAS DAMAGED UNINTENTIONALLY. ·THE CONDITION OF THE PATIENT¿S TISSUE (FRAIL/FRIABLE). NO ABNORMALITIES WERE DETECTED IN THE DHR. THEREFORE, A LIKELY FACTOR CAUSING EXCESSIVE BENDING (NOTICEABLY BENT THE DISTAL END OF THE INSERTION PORTION -REPORTED BY CUSTOMER) MIGHT BE THE FOLLOWING: ·THE SUBJECT DEVICE WAS INSERTED INTO THE ENDOSCOPE ABRUPTLY. THEREFORE, A BENDING FORCE WAS APPLIED TO THE INSERTION PORTION. ·THE SUBJECT DEVICE WAS FORCEFULLY INSERTED INTO THE EXCESSIVELY ANGULATED ENDOSCOPE. THEREFORE, A BENDING FORCE WAS APPLIED TO THE INSERTION PORTION. ·THE ENDOSCOPE WAS ABRUPTLY ADJUSTED THE ANGLE WHILE THE INSERTION PORTION WAS PROTRUDING FROM THE DISTAL END OF THE ENDOSCOPE. THEREFORE, A BENDING FORCE WAS APPLIED TO THE INSERTION PORTION. ·THE DISTAL END OF THE INSERTION PORTION WAS FORCEFULLY PUSHED AGAINST THE BODY TISSUE. THEREFORE, A BENDING FORCE WAS APPLIED TO THE INSERTION PORTION. HOWEVER, THE EXACT TIMING WHEN AND HOW A BENDING FORCE WAS APPLIED TO THE DISTAL END OF THE INSERTION PORTION CAUSING THE BENDING COULD NOT BE DETERMINED.

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: BRONCHOSCOPE 2.8 (WORKING CHANNEL) WITH SN (B)(4), LOADER CATH DEP SVS-C26N-06, LOT NUMBER WS136498-01, EXPIRATION DATE: 29FEB2024, AIRWAY SIZING KIT SVS-VSK-06, LOT NUMBER WS992808-01, EXPIRATION DATE 30JUN2023. THE DEVICE REFERENCED IN THIS REPORT HAS NOT YET BEEN RECEIVED BY OLYMPUS FOR PHYSICAL EVALUATION (ALTHOUGH IT IS ANTICIPATED). THE DEFINITIVE CAUSE OF THE USER'S EXPERIENCE CANNOT BE DETERMINED AT THIS TIME. THE INVESTIGATION IS ONGOING. THIS REPORT WILL BE UPDATED UPON COMPLETION OF THE INVESTIGATION OR UPON RECEIPT OF ADDITIONAL RELEVANT INFORMATION. THIS EVENT HAS BEEN REPORTED BY THE IMPORTER ON MDR# 2951238 - 2021 - 00347.

    Description of Event or Problem · 1

    IT IS REPORTED DURING A SPIRATION VALVE PROCEDURE FOR BRONCHOSCOPIC LUNG VOLUME REDUCTION (INDICATION: EMPHYSEMA) USING A DISPOSABLE BALLOON CATHETER, THE DISTAL TIP OF CATHETER WAS NOTICEABLY BENT WHEN IN VIEW THROUGH WORKING CHANNEL OF SCOPE. THE BEND DID NOT ALLOW PROPER NAVIGATION IN LEFT UPPER LOBE FOR ACCURATE SIZING. BALLOON WAS TAKEN OUT AND REPLACED WITH A NEW ONE. THE PATIENT EXPERIENCED ALMOST IMMEDIATE ATELECTASIS OF THE LEFT UPPER LOBE AND PNEUMOTHORAX. THE PATIENT WAS TAKEN TO INTERVENTIONAL RADIOLOGY (IR) FOR CHEST TUBE PLACEMENT, AND THEN TO THE INTENSIVE CARE UNIT (ICU). THERE WERE NO REPORTED CHALLENGES WITH THE PATIENT'S ANATOMY THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. THE PATIENT'S CURRENT CONDITION IS REPORTED TO BE GOOD WITH IMPROVEMENT IN HIS BREATHING AT HOME WITH DAILY EXERCISES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    901934 DISPOSABLE BALLOON CATHETER DISPOSABLE BALLOON CATHETER EOQ AOMORI OLYMPUS CO., LTD. B5-2C 14K 04953170047398

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Male Required Intervention| O