MAUDE Adverse Event Report: ZOLL CIRCULATION ZOLL IVTM ICY CATHETER; CENTRAL VENOUS CATHETER

Model Number	IC-3893
Medical Device Problem Codes	Fluid/Blood Leak (1250); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/14/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported complaint of "the icy catheter (lot # 142550) leak" was confirmed during the functional testing of the returned catheter.A water emission/leak was observed from the proximal infusion lumen opening and from the proximal luer during lumen crosstalk test.The probable root cause of the observed leak could be a latent material defect.Upon visual inspection, no physical damage to the catheter was observed.Noticed syringe attached to the in luer.During functional testing, all infusion ports and extension tubes were flushed without resistance.The catheter was connected to the pressurized inflation device and upon pressurizing the catheter, no leak was observed from the catheter balloons.The customer's reported complaint of " a pinhole leak from one of the balloons" was not confirmed; however, a water emission/leak were observed from the proximal infusion lumen opening and from the proximal luer during lumen crosstalk test.It is unlikely that the defective catheter was shipped.During manufacturing, all catheters are 100% inspected for leaks by subjecting them to pressure testing.Only units that passed are moved to the next process.Historical complaints were reviewed for information related to the reported complaint, and there was no previous history of complaint reported for icy catheter with lot number 142550.
Event or Problem Description
On the third day of ivtm therapy, the thermogard xp ivtm system generated an "air trap" alarm and the user noticed that the saline bag was empty.It was suspected that the icy catheter (lot #142550) was leaking.Since the rewarming phase of the therapy had been completed, the catheter was removed.After removing the catheter, the user flushed the catheter balloons with saline and noticed a pinhole leak from one of the balloons.It was suspected that the remaining of the 500-ml saline bag, after the system set-up, had infused into the patient's body.No consequences or impact to the patient.
Event or Problem Description
On the third day of ivtm therapy, the thermogard xp ivtm system generated an "air trap" alarm and the user noticed that the saline bag was empty.It was suspected that the icy catheter (lot #142550) was leaking.Since the rewarming phase of the therapy had been completed, the catheter was removed.After removing the catheter, the user flushed the catheter balloons with saline and noticed a pinhole leak from one of the balloons.It was suspected that the remaining of the 500-ml saline bag, after the system set-up, had infused into the patient's body.No device malfunction was reported on the tgxp console.No consequences or impact to the patient.
Additional Manufacturer Narrative
The reported complaint of "the icy catheter (lot # 142550) leak" was confirmed during the functional testing of the returned catheter.A water emission/leak was observed from the proximal infusion lumen opening and from the proximal luer during lumen crosstalk test.The probable root cause is weakened wall between the lumens, which survived pressure testing during manufacturing but resulted in a leak during the use.Upon visual inspection, no physical damage to the catheter was observed.Noticed syringe attached to the in luer.During functional testing, all infusion ports and extension tubes were flushed without resistance.The catheter was connected to the pressurized inflation device and upon pressurizing the catheter, no leak was observed from the catheter balloons.The customer's reported complaint of " a pinhole leak from one of the balloons" was not confirmed; however, a water emission/leak were observed from the proximal infusion lumen opening and from the proximal luer during lumen crosstalk test.It is unlikely that the defective catheter was shipped.During manufacturing, all catheters are 100% inspected for leaks by subjecting them to pressure testing.Only units that passed are moved to the next process.Historical complaints were reviewed for information related to the reported complaint, and there was no previous history of complaint reported for icy catheter with lot number 142550.

• Brand Name: ZOLL IVTM ICY CATHETER
• Common Device Name: CENTRAL VENOUS CATHETER
• Manufacturer (Section D): ZOLL CIRCULATION; 2000 ringwood ave.; san jose CA 95131
• MDR Report Key: 10518156
• Report Number: 3010617000-2020-00897
• Device Sequence Number: 2604391
• Product Code: NCX
• UDI-Device Identifier: 00849111075527
• UDI-Public: 00849111075527
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K101987
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/10/2020

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 Model Number: IC-3893
• Device Catalogue Number: 8700-0782-03
• Device Lot Number: 142550
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/28/2020
• Initial Date Received by Manufacturer: 09/10/2020
• Supplement Date Received by Manufacturer: 09/10/2020
• Initial Report FDA Received Date: 09/10/2020
• Supplement Report FDA Received Date: 09/10/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1