MAUDE Adverse Event Report: COOK INC ARNDT ENDOBRONCHIAL BLOCKER SET; CBI TUBE, TRACHEAL/BRONCHIAL

Model Number	N/A
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Concomitant products: olympus fiber optic cable (ptcb-e02) 2.1.Occupation: director of logistics.Pma/510(k) #: k160542.A follow-up report will be submitted should additional relevant information become available.
Event or Problem Description
It was reported that the balloon of a arndt endobronchial blocker set only inflated on one side rather than all the way around.Consequently, another device was used in its place.No adverse effects to the patient have been reported.Additional information regarding device and event details has been requested but is unavailable at the time of this report.
Additional Manufacturer Narrative
Investigation - evaluation: a review of the documentation including the drawing, instructions for use (ifu), manufacturing instructions (mi) and quality control, as well as a dimensional verification, functional test and visual inspection of the returned device was conducted during the investigation.One aebs catheter was returned for investigation.Upon physical examination, one side of the balloon was inflated with 2cc of air while the other was completely deflated.No biological matter was observed on the device.A functional test revealed that the initially inflated side was able to be inflated again and stay so properly.Furthermore, there is no indication that the device was manufactured out of specification.This complaint was able to be confirmed based on customer testimony as well as inspection of the returned device.Additionally, a document-based investigation evaluation was performed.Cook has concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.Process validation testing showed that the affected product¿s production processes meet established process outputs for the bonding of the silicone balloon to the catheter shaft.A review of the device history record (dhr) for the complaint lot (9625038) found no non-conformances.A database search found no other complaints related to lot 9625038.As there are adequate inspection activities established, objective evidence that the dhr was fully executed, no non-conformances, and no additional complaints from the same lot, it was concluded that there is no evidence that nonconforming product exists in house or in field.Cook also reviewed product labeling.The instructions for use (ifu), provides the following information to the user related to the reported failure mode: instructions for use: "for a french size 5.0 catheter, the recommended average inflation volume is.5 cc - 2.0 cc." how supplied: ¿store in a dark, dry, cool place.Avoid extended exposure to light.Upon removal from package, inspect the product to ensure no damage has occurred.¿ based on the information provided, examination of the returned device, and the results of our investigation, a definitive root cause was traced to component failure.The appropriate personnel have been notified.Per the quality engineering risk assessment no further action is required.Cook will continue to monitor for similar complaints.This report is required by the fda under 21 cfr part 803 and is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement contained herein is intended to be an admission that any cook device is defective or malfunctioned, that a death or serious injury occurred, nor that any cook device caused, contributed to, or is likely to cause or contribute to a death or serious injury if a malfunction occurred.
Event or Problem Description
Additional information received on 16oct2019 stated that the uneven balloon shape was noticed before the product was used.Therefore, there was no patient contact.

• Brand Name: ARNDT ENDOBRONCHIAL BLOCKER SET
• Common Device Name: CBI TUBE, TRACHEAL/BRONCHIAL
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 9192404
• Report Number: 1820334-2019-02598
• Device Sequence Number: 1840510
• Product Code: CBI
• UDI-Device Identifier: 00827002132795
• UDI-Public: (01)00827002132795(17)220327(10)9625038
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,other,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/14/2019

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: No Information
• Device Expiration Date: 03/27/2022
• Device Model Number: N/A
• Device Catalogue Number: C-AEBS-5.0-50-SPH
• Device Lot Number: 9625038
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/01/2019
• Initial Date Received by Manufacturer: 09/25/2019
• Supplement Date Received by Manufacturer: 10/16/2019
• Initial Report FDA Received Date: 10/15/2019
• Supplement Report FDA Received Date: 11/14/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 8 DA