MAUDE Adverse Event Report: ANGIODYNAMICS ANGIODYNAMICS; CARDIOVASCULAR PROCEDURE KIT

Catalog Number	H9656062093161
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Ischemia (1942)
Date of Event	07/01/2019
Type of Reportable Event	Serious Injury
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 recent angiodynamics complaint report was reviewed for the convenience kit and preceptor dts and manifolds product families for the failure modes "bond break/damaged" and "air bubbles." no adverse trends were indicated.Returned for evaluation was a bonded device assembly.The male luer lock from the manifold rotating adaptor was found to be broken off where it is bonded into the female luer lock of the 10" contrast injection line.No leak testing was performed due to the condition of the sample.There did not appear to be any manufacturing defects visible on the returned bonded assembly.Based on the sample evaluation and the manufacturing process controls in place to verify correct bonding of component, possible root causes of the damage may be due to the end user trying to tighten the bonded connection, or handling damage during transit.No other damage was noted to the returned sample.The directions for use supplied to the end user with the convenience kit contains the warning: "ensure that you are making secure connections when using this device to prevent the introduction of air into the system.All connections should be finger tightened.Over tightening can cause cracks and leaks to occur." examine product carefully for entrapped air and fully debubble prior to injection to minimize the potential for embolism.(b)(4).
Event or Problem Description
As reported by hospital in the (b)(6), while using an angiographic convenience kit, " the patient has had chest pains / ischemia and st elevations after air has entered the coronary.Patient has recovered." the device used in the reported procedure has been returned to angiodynamics for evaluation.

• Brand Name: ANGIODYNAMICS
• Common Device Name: CARDIOVASCULAR PROCEDURE KIT
• Manufacturer (Section D): ANGIODYNAMICS; 10 glens falls technical park; glens falls NY 12801
• MDR Report Key: 8845237
• Report Number: 1317056-2019-00097
• Device Sequence Number: 2088845
• Product Code: OEZ
• UDI-Device Identifier: H9656062093161
• UDI-Public: H9656062093161
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 07/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2022
• Device Catalogue Number: H9656062093161
• Device Lot Number: 5458141
• 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: 07/01/2019
• Initial Report FDA Received Date: 07/31/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other