MAUDE Adverse Event Report: ANGIODYNAMICS ANGIODYNAMICS; CARDIOVASCULAR PROCEUDRE KIT

Catalog Number	H965601910111
Medical Device Problem Code	Improper Flow or Infusion (2954)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It has been indicated that used and unused device samples will be returned for evaluation, however they have not yet arrived.A supplemental medwatch will be submitted upon completion of the investigation.((b)(4)).
Event or Problem Description
As reported, with a convenience kit, air bubbles were believed to be entering the line at the connection of the disposable transducer and the pressure monitoring line."the connections were then tightened, and eventually changed out." no air was injected and there was no patient injury.Samples are being returned to angiodynamics for evaluation.
Additional Manufacturer Narrative
A review of the device history records was performed for the indicated packaging and component lots for any deviations related to the reported defect of the complaint.The review confirms that the lots met all material, assembly and performance specifications.The june 2019 fluid management complaint report was reviewed for the convenience kit product family and the failure mode "device - air bubbles." no adverse trend was indicated.Thirteen unopened convenience kits were returned from the end user hospital no used samples were returned.The following inspection activities were performed on all 13 samples returned: visual/microscopic exam: as received, the pressure monitoring line (pml) and bonded component item numbers {40701722 and 40400052} were unopened.A visual inspection of the female and male luer lock of the pml and bonded component female luer using a microscope showed no visual defects.Functional check: bonded device: the male taper was verified to be within specification per manufacturing procedures, using iso taper gauge.Dimensional check: the female taper was verified to meet specification per manufacturing procedures, using the iso female taper gauge.The female threads were measured using calipers and found to be within specification.Pml: the male taper of the pml was verified to be within specification per manufacturing procedures, using iso taper gauge.Bonded component and pml the bonded device and pml was leak tested at 12 psi of air using a heise.The sample passed the leak test requirements per manufacturing procedures.The pml connected and disconnected to the bonded component three times.No connection issues were observed.The end user's complaint description cannot be confirmed.There were no manufacturing related defects noted in the returned sample.The samples were evaluated and was found visually, dimensional and functionally acceptable.Based on the sample evaluation the end user's complaint does not appear to be a manufacturing related issue.Possible root cause may be that the end user did not adequately secure connections between the pml and the bonded component or the device they were connecting to were not "finger tightened" prior to use as it is stated in the directions for use (dfu) provided to the end user in the reported kit.The dfu contains the following statements, "all connections should be finger tightened.Over tightening can cause cracks and leaks to occur that could result in embolism and or exposure to biohazards." (b)(4).

• Brand Name: ANGIODYNAMICS
• Common Device Name: CARDIOVASCULAR PROCEUDRE KIT
• Manufacturer (Section D): ANGIODYNAMICS; 10 glens falls technical park; glens falls NY 12801
• MDR Report Key: 8623261
• Report Number: 1317056-2019-00066
• Device Sequence Number: 16656381
• Product Code: OEZ
• UDI-Device Identifier: H965601910111
• UDI-Public: H965601910111
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/13/2019

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: 03/31/2022
• Device Catalogue Number: H965601910111
• Device Lot Number: 5450161
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/09/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/26/2019
• Supplement Date Received by Manufacturer: 04/26/2019
• Initial Report FDA Received Date: 05/20/2019
• Supplement Report FDA Received Date: 08/13/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1