MAUDE Adverse Event Report: ABBOTT VASCULAR ARMADA 35 PTA CATHETER; PERIPHERAL DILATATION CATHETER

Model Number	B2050-250
Medical Device Problem Codes	Inflation Problem (1310); Leak/Splash (1354); Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/02/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was received.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Event or Problem Description
It was reported that the procedure was performed to treat a lesion in the superficial femoral artery.A 5x250mm armada 35 percutaneous transluminal angioplasty (pta) catheter faced resistance with a non-abbott guide wire and non-abbott guiding catheter during advancement.The pta balloon failed to inflate, and the device failed to hold pressure.No tear was noted.A 5x200mm armada was used to successfully complete the procedure.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.
Additional Manufacturer Narrative
A visual, dimensional and functional inspection was performed on the returned balloon catheter.The reported difficulties were unable to be confirmed.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 similar incidents and/or complaints reported from this lot.Factors that may contribute to difficulty inflating the device may include, but are not limited to, damage to the device, contamination in the inflation lumen, patient anatomical morphology, patient disease state, inflation/deflation technique, contrast dilution, inadequate connection to the inflation device, and/or accessory device support.To help ensure this difficulty is not related to a manufacturing issue, all balloon catheters are inspected/tested in manufacturing.Based on the limited information provided, the investigation was unable to determine a conclusive cause for the reported difficult to advance, inflation problem and leak.There is no indication of a product quality issue with respect to manufacture, design or labeling.

• Brand Name: ARMADA 35 PTA CATHETER
• Common Device Name: PERIPHERAL DILATATION CATHETER
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 12204072
• Report Number: 2024168-2021-06308
• Device Sequence Number: 3802511
• Product Code: LIT
• UDI-Device Identifier: 08717648155246
• UDI-Public: 08717648155246
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K111899
• 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,Followup
• Report Date (Section B): 08/06/2021

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: 03/31/2024
• Device Model Number: B2050-250
• Device Catalogue Number: B2050-250
• Device Lot Number: 01009G2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/15/2021
• Initial Date Received by Manufacturer: 07/02/2021
• Supplement Date Received by Manufacturer: 08/05/2021
• Initial Report FDA Received Date: 07/21/2021
• Supplement Report FDA Received Date: 08/06/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CORDIS CATHETER; GLIDE WIRE; CORDIS CATHETER; GLIDE WIRE