MAUDE Adverse Event Report: MEDIVANCE, INC. ¿ 1725056 ARCTIC GEL PADS

Catalog Number 317-05-02

Device Problems Material Fragmentation (1261); Material Split, Cut or Torn (4008)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/20/2023

Event Type  malfunction  

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.H11: section a through f - the information provided by bd represents all the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.

Event Description

It was reported that the flow rate was not presented on the arctic sun device when using the defective arctic gel pad.The associate working for one of their distributors take a look into the pad and then found the defective part from the pad that had a tiny hole.It was working well after arctic gel pad was replaced with a new one and it was used with the same arctic sun instrument.The incident was occurred during use and no serious injury.Per follow up information received via email on 30oct2023, this issue related with flow rate was due to defective arctic gel pad but not device problem.The associate working for one of their distributors take a look into the pad and then found the defective part from the pad that had a tiny hole.It was working well after arctic gel pad was replaced with a new one and it was used with the same arctic sun instrument and replacement with a new arctic gel pad.

Event Description

It was reported that the flow rate was not presented on the arctic sun device when using the defective arctic gel pad.The associate working for one of their distributors take a look into the pad and then found the defective part from the pad that had a tiny hole.It was working well after arctic gel pad was replaced with a new one and it was used with the same arctic sun instrument.The incident was occurred during use and no serious injury.Per follow up information received via email on 30oct2023, this issue related with flow rate was due to defective arctic gel pad but not device problem.The associate working for one of their distributors take a look into the pad and then found the defective part from the pad that had a tiny hole.It was working well after arctic gel pad was replaced with a new one and it was used with the same arctic sun instrument and replacement with a new arctic gel pad.

Manufacturer Narrative

The reported issue was confirmed due to an air leak through the damaged/deformed pad connectors.However, the root cause of the damage to the pad connectors could not be determined.Although a root cause could not be definitively identified, based on the risk documentation review, a potential root cause for this type of failure could be that connectors damaged by supplier were received during manufacturing.However, there was insufficient information to confirm this potential root cause.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use were found adequate and state the following: "per the ifu: attach the pad¿s line connectors to the patient line manifolds.Begin circulating water through the pads using either patient temperature control mode (automatic) or water temperature control mode (manual).If the pads fail to prime or a significant continuous air leak is observed in the pad return line, check connections, then if needed replace the leaking pad.Once the pads are primed, assure the flow rate displayed on the control panel is greater than 1.7 liters per minute, which is the minimum flow rate for a full pad kit (4)." h11: section a through f - the information provided by bd represents all the known information at this time.Despite good faith efforts to obtain additional information, the complainant/reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.H3 other text: the actual/suspected device was inspected.

• Brand Name: ARCTIC GEL PADS
• Type of Device: ARCTIC GEL PADS
• Manufacturer (Section D): MEDIVANCE, INC. ¿ 1725056; 321 s taylor ave; suite 200; louisville 80027
• Manufacturer (Section G): MEDIVANCE, INC. ¿ 1725056; 321 s taylor ave; suite 200; louisville 80027
• Manufacturer Contact: xeeroy rada ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 18105314
• MDR Text Key: 328638544
• Report Number: 1018233-2023-08017
• Device Sequence Number: 1
• Product Code: DWJ
• UDI-Device Identifier: 10801741080064
• UDI-Public: (01)10801741080064
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: K142702
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/02/2024

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
• Device Operator: Health Professional
• Device Catalogue Number: 317-05-02
• Device Lot Number: NGGY5957
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/20/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/20/2023
• Initial Date FDA Received: 11/09/2023
• Supplement Dates Manufacturer Received: 04/02/2024
• Supplement Dates FDA Received: 04/04/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/19/2022
• 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): Other