MAUDE Adverse Event Report: COOK INC DOLPHIN BT CIAGLIA BALLOON-ASSISTED PERCUTANEOUS TRACHEOSTOMY INTRODUCER SET; JOH TUBE TRACHEOSTOMY AND TUBE CUFF

Model Number	N/A
Medical Device Problem Codes	Fluid/Blood Leak (1250); Material Rupture (1546)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/01/2017
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
The international customer reported that, when the operator increased the sodium chloride (nacl) pressure in the balloon to approximately 11 psi, the balloon portion of the dolphin bt ciaglia balloon-assisted percutaneous tracheostomy introducer device ruptured after approximately 15 seconds.Nacl leaked out of the balloon.The operator proceeded to insert the tracheal cannula as originally intended, and it occurred with no problems.As a result, the procedure occurred with no patient adverse events or additional medical intervention on the first try.The device is reportedly available for return; however, as of the date of this report, no device has yet been received for evaluation.
Additional Manufacturer Narrative
Investigation ¿ evaluation.A review of the dimensional verification, complaint history, device history record (dhr), documentation, drawing, instructions for use (ifu), manufacturing instructions, quality control, specifications, and a visual inspection and functional evaluation of the returned device were conducted during the investigation.The visual inspection of the returned device confirmed that a longitudinal burst ran the entire length of the balloon.The diameter of the balloon was unable to be verified due to the longitudinal rupture.The balloon was leak tested with air and water, and the presence of the burst was confirmed.Additionally, 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 indicated that the lot met all finished goods release criteria.It should be noted there were no other reported complaints for this lot number.Also, it was observed that the physician inflated the balloon to specification as noted in the instructions for use; however, no information was provided regarding the preparation of the device and the state of the balloon prior to patient contact based on the information provided, the examination of the returned product, and the results of our investigation, a definitive root cause could not be determined.Per the quality engineering risk assessment, no further action is required.Cook medical has notified the appropriate personnel and will continue to monitor this device via the complaints database for similar complaints.

• Brand Name: DOLPHIN BT CIAGLIA BALLOON-ASSISTED PERCUTANEOUS TRACHEOSTOMY INTRODUCER SET
• Common Device Name: JOH TUBE TRACHEOSTOMY AND TUBE CUFF
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 7039657
• Report Number: 1820334-2017-01357
• Device Sequence Number: 1145457
• Product Code: JOH
• UDI-Device Identifier: 00827002361027
• UDI-Public: (01)00827002361027(17)190630(10)7556797
• Combination Product (Y/N): N
• Initial Reporter Country: SE
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 02/15/2018

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-2400
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 11/01/2017
• Supplement Date Received by Manufacturer: 02/15/2018
• Initial Report FDA Received Date: 11/16/2017
• Supplement Report FDA Received Date: 02/15/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 62 YR
• Patient Weight: 52