MAUDE Adverse Event Report: COVIDIEN MFG SOLUTIONS S.A. CHAMELEON; CATHETER, CONTINUOUS FLUSH

Model Number CH06-40-75US

Device Problems Deflation Problem (1149); Detachment of Device or Device Component (2907)

Patient Problem Unintended Radiation Exposure (4565)

Event Date 01/24/2022

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, the physician observed and reported that the balloon was difficult to deflate (just an observation not a quality issue).It was stated that when the balloon was being removed from the patient, the balloon was caught in the introducer sheath (6 french gauge (fr), cordis) and as result the balloon separated from the catheter and was broken into two pieces (the broke in two pieces refer to the catheter as one piece and the balloon as the second piece.The balloon remained intact).The balloon was retrieved without surgical intervention because it broke within the sheath instead of the vessel.It was stated that to resolve the issue the balloon was removed together with the introducer sheath and the procedure was completed.X-ray/ fluoro was required to check if all pieces were accounted for and the balloon was also examined to ensure it was intact.All pieces were retrieved from the patient.The catheter was not repaired.There was no leak and no luer adapter issue.Tego was not utilized.There was nothing unusual observed on the device prior to use, flushing was done per instruction for use (ifu) and there was no unexpected result, no other products were utilized with the device and no other defects/damages were found on the product.There was no resistance encountered when advancing the device, the device did not pass through a previously deployed stent, the reported balloon was inflated by hand with a syringe, the inflation fluid used was standard contrast fluid mix, the device did not move while inflated, no excessive force was used (detachment was spontaneous), and there was no additional medical intervention required to retrieve the detached item.There was no patient symptoms or complications associated with this event.There was no vessel damage, there was no blood loss and blood transfusion was not required.

• Brand Name: CHAMELEON
• Type of Device: CATHETER, CONTINUOUS FLUSH
• Manufacturer (Section D): COVIDIEN MFG SOLUTIONS S.A.; edificio b20, calle #2; alajuela 20101 ; CS 20101
• Manufacturer (Section G): COVIDIEN MFG SOLUTIONS S.A.; edificio b20, calle #2; alajuela 20101 ; CS 20101
• Manufacturer Contact: clay chandler ; 5920 longbow drive; boulder, CO 80301 ; 3035306409
• MDR Report Key: 13642705
• MDR Text Key: 286557614
• Report Number: 3009211636-2022-00057
• Device Sequence Number: 1
• Product Code: KRA
• UDI-Device Identifier: 07290016745023
• UDI-Public: 07290016745023
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K170635
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/01/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/29/2022
• Device Model Number: CH06-40-75US
• Device Catalogue Number: CH06-40-75US
• Device Lot Number: 22002937
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/11/2022
• 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
• Patient Outcome(s): Required Intervention