MAUDE Adverse Event Report: ABBOTT VASCULAR INC. ARMADA; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number	F2020-020
Medical Device Problem Codes	Deflation Problem (1149); Difficult to Remove (1528); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/16/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.
Event or Problem Description
It was reported that in a procedure to treat a below the knee (btk) occlusion.After the 2x20mm armada 14 balloon dilatation catheter (bdc) was inflated 4-5 times at an unknown pressure, the balloon did not completely deflate.The bdc was removed from the patient.There was no adverse patient effect and no clinically significant delay reported in the procedure.No additional information was provided.
Additional Manufacturer Narrative
Visual analysis was performed on the returned device.The reported deflation issue, difficulty removing the device from the introducer sheath and guiding catheter could not be replicated in a testing environment due to the condition of the returned device.The reported difficulty removing the device from the anatomy could not be replicated in a testing environment as it was based on operational circumstances.The production record and corrective and preventive actions (capa) review was performed and revealed no indication of a product quality issue.Additionally, a review of the complaint history identified no other similar complaints from this lot.It was reported by the account that the balloon was removed partially inflated.It should be noted the percutaneous transluminal angioplasty (pta) catheter, armada 14 xt, over the wire (otw), global, instruction for use (ifu) states: withdraw the deflated catheter and guide wire from the sheath / guiding catheter through the hemostatic valve.In this case, it is likely that the ifu violation contributed to the reported difficulty removing the device.Additionally, the contrast mix used in the procedure was 1/3 contrast iomeron 300, 2/3 saline.It should be noted that the pta, armada 14 xt, otw, global, ifu specified that the contrast is contrast diluted 1:1 with normal saline.In this case, since the contrast ratio used was less than the required percentage and it is unknown if the ifu violation caused or contributed to the reported complaint.Based on the information reported through the complaint report, a conclusive cause for the reported deflation issue could not be determined.The reported difficulty removing the device from the anatomy, introducer sheath and guiding catheter appear to be related to operational context.Possible factors that may contribute to difficulty deflating the balloon include, but are not limited to, deflation technique, tortuous anatomy, loose connection with the indeflator, contamination in the inflation lumen or damage to the guide wire and/or inflation lumen.It was reported that the bdc was inflated and deflated four to five times during the procedure as well as slightly repositioned within the range of the same lesion.The physician was able to successfully complete the initial inflation/deflation cycles, which suggests a product quality issue did not contribute to the reported difficulties.In this case, it is possible that the repositioning of the device may have resulted in the noted inner member and outer member (shaft) stretching proximally from proximal balloon seal which subsequently contributed to the reported deflation issue; however, this cannot be confirmed.Furthermore, it is likely that the reported difficulty removing the device from the anatomy, introducer sheath and guiding catheter was due to the balloon not being able to fully deflate.There is no indication of a product quality issue with respect to manufacture, design or labeling.H6: medical device problem code 2017 (incorrect removal).D1 correction: brand name updated.D2a correction: common device name updated.D3 correction: name, address updated.
Event or Problem Description
Subsequent to the initial report being filed, it was reported that resistance was noted during removal with the anatomy, guide catheter and introducer.Additionally, the contrast ratio was 1/3 contrast iomeron 300, 2/3 saline.No additional information was provided.

• Brand Name: ARMADA
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): ABBOTT VASCULAR INC.; 3200 lakeside drive; santa clara CA 95054 2807
• Manufacturer (Section G): ABBOTT VASCULAR COSTA RICA, REG # 3009564766; 52 calle 3 b31 coyol free zone; el coyol alajuela ; CS
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 19264171
• Report Number: 2024168-2024-05593
• Device Sequence Number: 15123284
• Product Code: LIT
• UDI-Device Identifier: 08717648182938
• UDI-Public: (01)08717648182938(17)260731(10)30817G1
• Combination Product (Y/N): N
• Initial Reporter Country: SI
• PMA/510(K) Number: K121352
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/23/2024
• 2 Devices were Involved in the Event: 1 2

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: 07/31/2026
• Device Model Number: F2020-020
• Device Catalogue Number: F2020-020
• Device Lot Number: 30817G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/16/2024
• Supplement Date Received by Manufacturer: 07/10/2024
• Initial Report FDA Received Date: 05/07/2024
• Supplement Report FDA Received Date: 07/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/17/2023
• 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
• Patient Age: 52 YR
• Patient Sex: Male
• Patient Weight: 52 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White