MAUDE Adverse Event Report: GYRUS ACMI, INC. EZDILATE BALLOON DILATOR (FW) 18-19-20

Model Number BD-400P-2080

Device Problems Deflation Problem (1149); Difficult to Remove (1528)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/19/2023

Event Type  malfunction  

Manufacturer Narrative

H7: upon review, this event has been associated with z # tbd / olympus ref # (b)(4).A physical device inspection could not be performed on this device, as it was reported that the customer had discarded the device.The legal manufacturer (lm) however has conducted an investigation with research & development team.The investigation concluded that this nonconformance observed in this complaint was categorized as a process defect.An exhaustive revision of the process was completed, founding that occlusion partial or total was generated in the proximal bonding station due to misalignment of the d-mandrel or mandrel during the preparation for bonding process.The operator had not enough visibility to ensure the correct position of the d-mandrel or mandrel, causing melting material smearing occluding partial or total the diameter of the extrude.Causing two events, the first was the diameter is completely occluded which would prevent the balloon from inflating.And the second event would be that the diameter was partially occluded which would cause it to take longer to inflate or deflate.As a containment action, awareness was given to all operators on the line about the root cause of the complaint, and a quality alert was posted in the proximal bonding station.As a corrective action the process was improved by adding an additional inspection station, also a lighted magnifying glass was installed to check the preparation prior to the bonding process to ensure proper preparation.After bonding operation, the operator uses the magnifying glass to ensure that the mandrel still in the proper position.The actions were implemented on (b)(6) 2023.Per lm, the dhr for the finished device (159-24673-06 / (b)(6)) was reviewed; no abnormalities in documentation or process were noted.A capa history review was performed on 16oct2023 and found zero currently opened or closed capas related to the failure(s).Three documents were issued as a result of the large increase of complaints regarding the nordson ezdilate balloon dilator product family.As a result, a scar (scr-0000589), stop-ship (ss-300203), and hha (fy24-osta-08) has been issued to discuss additional actions and scope.These discussions are still ongoing as of 16oct2023 but will be documented in hha (fy24-osta-08).Olympus will continue to monitor field performance for this device.

Event Description

The customer reported to olympus that while using the ezdilate balloon dilator for a therapeutic procedure, the user was unable to pull this device from the scope after it was dilated.The issue occurred at the end of the case.The procedure did not need to be prolonged, and patient¿s anesthesia or sedation was not extended.Procedure was completed by cutting the balloon from the catheter to remove from the scope.The issue did not affect the outcome of the procedure and no medical interventions were required.Device connected to subject device during malfunction was an inflation device for endoscopic balloon dilatation model# maj-1740.There were no reports of patient harm or impact associated with this event.Related patient identifier: (b)(6).

Event Description

Related patient identifiers: (b)(6) bd-400p-2080 sn (b)(6 (b)(3) (b)(6) 2023, (b)(6) bd-400p-2080 sn (b)(6) (b)(3) (b)(6) 2023, and (b)(6) bd-400p-2080 sn unknown (b)(3) (b)(6) 2023.

Manufacturer Narrative

This report is being supplemented to provide a correction to previously reported information.Mfr report # (b)(4).Patient identifier: (b)(6).Please see updates to b5, g3, g6, h6, h7 and h10.H7: upon review, this event has been associated with z # tbd / olympus ref # fy24-osta-07 a physical device inspection could not be performed on this device, as it was reported that the customer had discarded the device.The legal manufacturer (lm) however has conducted an investigation with research & development team.The investigation concluded that this nonconformance observed in this complaint was categorized as a process defect.An exhaustive revision of the process was completed, founding that occlusion partial or total was generated in the proximal bonding station due to misalignment of the d-mandrel or mandrel during the preparation for bonding process.The operator had not enough visibility to ensure the correct position of the d-mandrel or mandrel, causing melting material smearing occluding partial or total the diameter of the extrude.Causing two events, the first was the diameter is completely occluded which would prevent the balloon from inflating.And the second event would be that the diameter was partially occluded which would cause it to take longer to inflate or deflate.As a containment action, awareness was given to all operators on the line about the root cause of the complaint, and a quality alert was posted in the proximal bonding station.As a corrective action the process was improved by adding an additional inspection station, also a lighted magnifying glass was installed to check the preparation prior to the bonding process to ensure proper preparation.After bonding operation, the operator uses the magnifying glass to ensure that the mandrel still in the proper position.The actions were implemented on june-26-2023.Per lm, the dhr for the finished device (159-24673-06 / 375543) was reviewed; no abnormalities in documentation or process were noted.A capa history review was performed on 16oct2023 and found zero currently opened or closed capas related to the failure(s).Three documents were issued as a result of the large increase of complaints regarding the nordson ezdilate balloon dilator product family.As a result, a scar (scr-0000589), stop-ship (ss-300203), and hha (fy24-osta-07) has been issued to discuss additional actions and scope.These discussions are still ongoing as of 16oct2023 but will be documented in hha (fy24-osta-07).Olympus will continue to monitor field performance for this device.

• Brand Name: EZDILATE BALLOON DILATOR (FW) 18-19-20
• Type of Device: DILATOR
• Manufacturer (Section D): GYRUS ACMI, INC.; 800 west park drive; westborough MA 01581
• Manufacturer (Section G): GYRUS ACMI, INC.; 800 west park drive; westborough MA 01581
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 18284284
• MDR Text Key: 330826575
• Report Number: 3003790304-2023-00441
• Device Sequence Number: 1
• Product Code: KNQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 12/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: BD-400P-2080
• Device Lot Number: 381893
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/13/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: INFLATION DEVICE MODEL# MAJ-1740.