MAUDE Adverse Event Report: AOMORI OLYMPUS CO., LTD. DISPOSABLE BALLOON CATHETER

Model Number	B5-2C
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	Pneumothorax (2012)
Date of Event	05/19/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.
Event or Problem Description
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.
Additional Manufacturer Narrative
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
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).

• Brand Name: DISPOSABLE BALLOON CATHETER
• Common Device Name: DISPOSABLE BALLOON CATHETER
• Manufacturer (Section D): AOMORI OLYMPUS CO., LTD.; 2-248-1 okkonoki; kuroishi-shi, aomori 036-0 357; JA 036-0357
• Manufacturer (Section G): AOMORI OLYMPUS CO., LTD.; 2-248-1 okkonoki; kuroishi-shi, aomori 036-0 357; JA 036-0357
• Manufacturer Contact: kazutaka matsumoto ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 11999855
• Report Number: 8010047-2021-07553
• Device Sequence Number: 1072872
• Product Code: EOQ
• UDI-Device Identifier: 04953170047398
• UDI-Public: 04953170047398
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K962901
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: B5-2C
• Device Lot Number: 14K
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/19/2021
• Supplement Date Received by Manufacturer: 01/14/2022; 07/15/2022
• Initial Report FDA Received Date: 06/15/2021
• Supplement Report FDA Received Date: 02/08/2022; 07/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Age: 64 YR
• Patient Sex: Male
• Patient Weight: 95 KG