MAUDE Adverse Event Report: MEDTRONIC IRELAND ATTAIN CLARITY; CATHETER, PERCUTANEOUS

Model Number	6225
Medical Device Problem Code	Deflation Problem (1149)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/11/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that the balloon catheter lumen failed and the balloon filled with contrast.Deflation difficulty was also experienced and the balloon eventually collapsed into the delivery platform and everted upon removal.No patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
Product event summary: the balloon catheter was returned and analyzed.The analysis indicated that the mechanical operation of the balloon catheter was occluded.The balloon was ruptured.Visual analysis of the balloon catheter indicated damage during use.The analyst noted the balloon catheter was returned without the inflation syringe and the stop cock for the inflation valve was in the 'on' position.There is contrast in the infusion port of the balloon catheter.The is contrast in the balloon valve of the balloon catheter.There is contrast in the balloon port of the balloon catheter.There is blood and contrast in the balloon of the balloon catheter.The balloon is ruptured at the proximal end of the balloon.If information is provided in the future, a supplemental report will be issued.

• Brand Name: ATTAIN CLARITY
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• MDR Report Key: 9540762
• Report Number: 9612164-2020-00042
• Device Sequence Number: 2246139
• Product Code: DQY
• UDI-Device Identifier: 00643169530102
• UDI-Public: 00643169530102
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K121219
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/08/2020

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 Expiration Date: 09/30/2021
• Device Model Number: 6225
• Device Catalogue Number: 6225
• Device Lot Number: 0009947589
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/20/2019
• Initial Date Received by Manufacturer: 12/11/2019
• Supplement Date Received by Manufacturer: 01/06/2020
• Initial Report FDA Received Date: 01/02/2020
• Supplement Report FDA Received Date: 01/08/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 57 YR
• Patient Weight: 90