MAUDE Adverse Event Report: DXTERITY; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Model Number	DXT5JR40
Medical Device Problem Codes	Deformation Due to Compressive Stress (2889); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/17/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluation summary: one 5fr dexterity catheter was received for analysis.The catheter was kinked, flattened, and evidence of a torsional kink on the shaft of the catheter approx.46.2cm distal to the strain relief.The od was measured and confirmed to be 0.067inch with the spec being 0.070 max.The id was measured and confirmed to be 0.044 with spec being 0.042 min.No damage was noted to the distal tip.No other damage was noted to the remainder of the device.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
During a procedure an attempt was made to use two dexterity catheters to treat a lesion in the rca and lm arteries.There was no damage noted to either device.Devices were removed from the packaging per ifu.There was no resistance noted while removing the devices from packaging.A brachial approach was used for the procedure.The devices were inspected with issues noted.The first device was prepped per ifu.It was reported that this device was kinked in the middle of the catheter.The kink occurred while the device was in the patient.Excessive force was not used and the device was not excessively torqued.Resistance was not experienced.It was reported that the second device seemed to be kinked.The kink was noted on the device shaft while torquing the catheter to engage the artery.The device was excessively torqued.Resistance was not experienced and excessive force was not used.The patient is alive with no injury.

• Brand Name: DXTERITY
• Common Device Name: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• MDR Report Key: 12505055
• Report Number: 1220452-2021-00052
• Device Sequence Number: 3375793
• Product Code: DQO
• UDI-Device Identifier: 00643169689350
• UDI-Public: 00643169689350
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K161287
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/21/2021

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: 04/08/2024
• Device Model Number: DXT5JR40
• Device Catalogue Number: DXT5JR40
• Device Lot Number: 60290190
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/07/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/16/2021
• Initial Report FDA Received Date: 09/21/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/08/2021
• 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