MAUDE Adverse Event Report: ATRICURE, INC. CRYOICE CRYOSPHERE CRYO-ABLATION PROBE

Model Number	CRYOS
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/30/2022
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2021 when preparing for a modified pectus excavatum procedure, the cryos probe was connected to the acm generator, laid on a tabletop and a test freeze was initiated.When the probe reached -40 degrees, the acm counted down for about 10 seconds and then scrub technician vented it by pressing the n2o manual exhaust knob.When doing this a loud "pop" sound occurred and the device handle separated.There was no patient harm.During device evaluation, it was observed that the exhaust crimp sleeve was not present in the device.This discovery escalated this product problem to a reportable event per part 803 on (b)(6) 2022.
Additional Manufacturer Narrative
(b)(4) the complaint was confirmed.  the internal crimp sleeve component was not properly assembled to the exhaust tube.  the exhaust tube slid loose from the mating barb which caused the loud noise.  atricure is conducting an investigation to better understand the circumstances involving the improperly assembled crimp sleeve.

• Brand Name: CRYOICE CRYOSPHERE CRYO-ABLATION PROBE
• Common Device Name: CRYOICE CRYOSPHERE CRYO-ABLATION PROBE
• Manufacturer (Section D): ATRICURE, INC.; 7555 innovation way; mason OH 45040
• Manufacturer (Section G): ATRICURE, INC.; 7555 innovation way; mason OH 45040
• Manufacturer Contact: john ehlert ; 7555 innovation way; mason, OH 45040 ; 5136448220
• MDR Report Key: 14950614
• Report Number: 3011706110-2022-00024
• Device Sequence Number: 20559175
• Product Code: GXH
• UDI-Device Identifier: 00818354016321
• UDI-Public: 00818354016321
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K182565
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/07/2022

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: 08/01/2024
• Device Model Number: CRYOS
• Device Catalogue Number: A001009
• Device Lot Number: 113029
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/09/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/15/2022
• Initial Report FDA Received Date: 07/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/13/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ACM: 44569-05
• Patient Sex: Unknown