MAUDE Adverse Event Report: COOK INC DOLPHIN BT; JOH TUBE TRACHEOSTOMY AND TUBE CUFF

Model Number	N/A
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/06/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The event is currently under investigation.A follow-up report will be submitted upon receipt of additional information or completion of the investigation.
Event or Problem Description
It was reported by the international customer that, during the pressurization of the balloon contained in the dolphin bt ciaglia balloon-assisted percutaneous tracheostomy introducer set with versa tube, the balloon burst.The customer further elaborated that there was no injury to the patient, no parts of the device remained inside the cavity of the patient, and there were no patient adverse effects due to the occurrence.No further information was provided by the reporter, and the product is reportedly not available for return.
Additional Manufacturer Narrative
Additional information: the event occurred during a tracheostomy procedure, which was completed using a different system.Investigation ¿ evaluation: a review of the complaint history, device history record, drawing, quality control, and specifications was conducted during the investigation, and no issues were found related to the reported issue.The complaint device was not returned; therefore, no physical examinations could be performed.However, a document based investigation evaluation was performed.There is no evidence to suggest the product was not made to specifications.A review of the device history record shows no nonconforming events which could contribute to this failure mode.It should be noted there was one other complaint reported for this lot number.Based on the information provided, no product returned, and the results of our investigation; a definitive root cause could not be determined.Per the risk assessment, no further action is warranted.Monitoring will continue to be performed for similar complaints.

• Brand Name: DOLPHIN BT
• Common Device Name: JOH TUBE TRACHEOSTOMY AND TUBE CUFF
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 6879850
• Report Number: 1820334-2017-03271
• Device Sequence Number: 1222138
• Product Code: JOH
• UDI-Device Identifier: 00827002235489
• UDI-Public: (01)00827002235489(17)190531(10)7771925
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K093469
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/15/2017

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: N/A
• Device Catalogue Number: C-PTBS-2100-VT7
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/07/2017
• Supplement Date Received by Manufacturer: 10/17/2017
• Initial Report FDA Received Date: 09/20/2017
• Supplement Report FDA Received Date: 11/15/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1