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

Model Number	A2015-080
Medical Device Problem Codes	Difficult to Remove (1528); Material Separation (1562); Improper or Incorrect Procedure or Method (2017); Difficult to Advance (2920)
Health Effect - Clinical Code	Vessel Or Plaque, Device Embedded In (1204)
Date of Event	09/17/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Product performance engineering reviewed the incident information; however, the product was not returned to abbott vascular for analysis.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history identified no other incidents and/or complaints reported from this lot.The device was prepped prior to use without any issue noted, which would suggest that the device was not damaged prior to use.It should be noted that the instructions for use (ifu), pta, catheter, armada 14 states: inflation in excess of the rated burst pressure may cause the balloon to rupture.Use of a pressure monitoring device is recommended.In this case, the physician is aware of the ifu violation and the balloon inflation above rated burst pressure.The investigation determined the reported difficulties appear to be related to operational circumstances of the procedure.Based on the reported information, during advancement and retraction, the balloon catheter encountered resistance with the totally occluded, heavily calcified, and moderately tortuous anatomy.After the inflation above rated burst pressure, it is likely that manipulation and /or inadvertent mishandling against resistance resulted in the balloon separation.Additionally, the treatment appears to be related to the operational context of the procedure.There is no indication of a product quality issue with respect to manufacture, design or labeling; therefore, no corrective action is required.
Event or Problem Description
It was reported that the procedure was to treat a chronically total occluded (cto), heavily calcified, and moderately tortuous lesion in the left anterior tibial artery.A 1.5x80mm armada 14 pta balloon catheter (bdc) was prepped outside the anatomy according to the instructions for use without any issues.On advancing the bdc, resistance with the anatomy was felt and force was applied.The balloon was inflated once to 20 atmospheres.During removal of the bdc, resistance with the calcification was felt and only the shaft of the bdc came out.A horizontal separation at the level of the balloon had occurred and was confirmed via angiography.Both parts of the balloon with markers remained inside the vessel caught on the calcification.Unspecified armada 14 bdcs were used for dilatation prior to snaring out the proximal piece of the balloon.Several additional attempts were made to remove the distal piece; however, this was unsuccessful.A 3x100mm xpert pro stent was implanted to embed the remaining separated portion of the balloon to the vessel wall.A delay of 45-50 minutes was reported.The final result was better blood flow to the foot.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: 10651497
• Report Number: 2024168-2020-08395
• Device Sequence Number: 4283634
• Product Code: DQY
• UDI-Device Identifier: 08717648155925
• UDI-Public: 08717648155925
• Combination Product (Y/N): N
• Initial Reporter Country: DA
• PMA/510(K) Number: K102705
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/08/2020

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?: 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?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/17/2020
• Initial Report FDA Received Date: 10/08/2020
• 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: Required Intervention