MAUDE Adverse Event Report: ABBOTT VASCULAR ARMADA 14 PTA CATHETER; PERIPHERAL DILATATION CATHETER

Model Number	A2015-080
Medical Device Problem Codes	Material Separation (1562); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	11/11/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is expected to be returned for investigation.It has not yet been received.A follow-up report will be submitted with all additional relevant information.
Event or Problem Description
It was reported that the during device unpacking, the side arm of the device detached.The device was not used and there was no patient involvement.No additional information regarding this issue was provided.
Additional Manufacturer Narrative
H6: medical device problem code: 2017 - use after damage.A visual inspection was performed on the returned device and the reported separation was confirmed.The inner member and the outer member were noted to be separated from the side arm luer.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Based on the review of similar incidents there is no indication of a lot specific product quality issue.There was no damage noted to the balloon catheter during the inspection prior to preparation which suggests a product quality issue with respect to manufacture, design or labeling did not contribute to the reported difficulties.It should be noted that the armada 14, global, ce, instructions for use (ifu) states: carefully inspect the catheter prior to use to verify that it has not been damaged during shipment and that its size, shape and condition are suitable for the procedure for which it is to be used.Do not inflate the pta catheter during preparation of the device.In this case, the reported ifu violation of used after damage was noted and inflated before use does not appear to have caused the reported separation.The investigation determined the reported separation appears to be related to operational circumstances of the procedure.Based on the reported information, during device preparation, the device was wiped with a wet gauze likely stretching the proximal shaft causing the inner and outer member separation from the hub.The device was then inflated and deflated outside the anatomy to identify additional issues with the balloon.The device was then used as a support catheter.The noted damages to the inner, outer members and balloon likely occurred during retraction of the devices.There is no indication of a product quality issue with respect to manufacture, design or labeling; therefore, no corrective action is required.H6: patient code 2645 - removed.
Event or Problem Description
Subsequent to the initial report, additional information was which indicated that the side arm separated during device preparation and the device was pressurized outside the patient anatomy.The device was used in the anatomy as a support catheter; however, no attempt was made to pressurize the balloon inside the patient anatomy.No additional information was provided.

• Brand Name: ARMADA 14 PTA CATHETER
• Common Device Name: PERIPHERAL DILATATION CATHETER
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 10939387
• Report Number: 2024168-2020-10151
• Device Sequence Number: 584183
• Product Code: DQY
• UDI-Device Identifier: 08717648155925
• UDI-Public: 08717648155925
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K102705
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/11/2021

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: 07/31/2023
• Device Model Number: A2015-080
• Device Catalogue Number: A2015-080
• Device Lot Number: 0020441
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/08/2021
• Initial Date Received by Manufacturer: 11/11/2020
• Supplement Date Received by Manufacturer: 02/08/2021
• Initial Report FDA Received Date: 12/03/2020
• Supplement Report FDA Received Date: 02/11/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1