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

Model Number B1070-040

Device Problems Material Rupture (1546); Improper or Incorrect Procedure or Method (2017)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/23/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device is expected to be returned for evaluation.It has not yet been received.A follow report will be submitted with all additional relevant information.

Event Description

It was reported that the procedure was performed to treat 2 lesions, one in the arteriovenous (av) graft and one at the venous anastomosis due to high grade stenosis.The venous anastamosis of the av graft would not open completely and an angiogram showed residual stenosis, therefore an absolute pro stent was deployed.Additional angioplasty was attempted as standard practice using a 7.0x40mm armada 35 balloon but the balloon ruptured at 20atm on the third inflation.The armada 35 was replaced with a non-abbott 7mmx4cm high pressure balloon to successfully completely the procedure.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

Product performance engineering reviewed the complaint information and analysis of the returned unit.A review of the lot history record revealed no manufacturing nonconformities that would have contributed to this complaint.Additionally, a review of the complaint history of the reported lot revealed no other similar complaints.It should be noted that the instructions for use, pta, armada 35 / armada 35 ll, global, ce, costa rica, section 1 description states: the balloon is inflated using the side leg port, at which the balloon expands to a known diameter at specific pressure.The working pressure range for the balloon is between the nominal pressure and the rated burst pressure.All balloons distend to sizes above the nominal diameter at pressures greater than the nominal pressure.Additionally, in section iv, warnings/precautions it states: inflation in excess of the rated burst pressure may cause the balloon to rupture.In this case the reported ifu violation likely did cause or contribute to the reported material rupture.Based on the information provided, the balloon rupture was due the anatomical conditions related to the circumstances of the procedure.In this case, it is likely that the balloon pressurized as many as three times above the recommended rbp of 15 atm in order to overcome the anatomical conditions, led to the balloon rupture.The armada 35 balloon is a compliant (elastomeric) balloon which expands to a known diameter at specific pressure.The working pressure range for the balloon is between the nominal pressure and the rated burst pressure.Compliant balloons distend to sizes above the nominal diameter at pressures greater than the nominal pressure.Noncompliant (high-pressure) balloons are typically used for applications in which the balloon needs to expand to a specific diameter and exert high pressure to open a blockage or dilate the vasculature.Being that the armada 35 is a compliant balloon, they are inflated by volume, rather than pressure.Able to stretch 100% to 800%, they are often used in applications that require the balloon to fully conform to or occlude the anatomy.Based on the reported case information, user technique in conjunction with challenging lesion characteristics likely contributed to the reported difficulties, as the armada balloon likely conformed to the blockage as designed, leading the physician to inflate above rbp.There is no indication to suggest a product quality issue with respect to manufacture, design, or manufacture, or labeling of the armada 35 device.

• Brand Name: ARMADA 35 PTA CATHETER
• Type of Device: PERIPHERAL DILATATION CATHETER
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 10845216
• MDR Text Key: 219569948
• Report Number: 2024168-2020-09566
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 08717648154782
• UDI-Public: 08717648154782
• Combination Product (y/n): N
• PMA/PMN Number: K111899
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 12/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2023
• Device Model Number: B1070-040
• Device Catalogue Number: B1070-040
• Device Lot Number: 00423G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/24/2020
• Date Manufacturer Received: 12/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ABSOLUTE PRO
• Patient Age: 50 YR
• Patient Weight: 93