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

Model Number B1080-040

Device Problems Improper or Incorrect Procedure or Method (2017); Material Too Soft/Flexible (4007)

Patient Problem Intimal Dissection (1333)

Event Date 05/15/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).The customer reported the device is not returning.Investigation is not yet complete.A follow up report will be submitted with all additional relevant information.

Event Description

It was reported that the procedure was performed to treat a atrioventricular fistula (avf).The 8x40mm armada 35 balloon was pressurized to 18 atmospheres (atm) but the waist would not resolve.The device was replaced with an 8x40mm non-abbott high pressure balloon.The waist opened at 23 atm.The completion angiogram showed extravasation of contrast.The physician was uncertain if the armada 35 caused or contributed to the dissection.An 8x40mm non-abbott covered stent was deployed and post-dilated with an unspecified 8mm balloon.The completion angiogram showed a widely patent avf with brisk flow of contrast.There was no further leak from the vein.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

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 reported patient effect of dissection is listed in the instructions for use (ifu) armada 35, armada 35 long length percutaneous transluminal angioplasty (pta) catheter, as a known patient effect of the procedure.It should be noted that the ifu, pta, armada 35 / armada 35 ll, global, ce, costa rica instructions for use states: inflation in excess of the rated burst pressure (rbp) may cause the balloon to rupture.Use of a pressure monitoring device is recommended.In this case the reported ifu violation does not appear to have caused or contributed to the reported dissection or reported difficulties as the armada balloon was replaced with an 8x40mm non-abbott high pressure balloon and anatomy/waist opened at 23atm.The investigation determined the reported irregular inflation issue appears to be related to user technique in conjunction with challenging lesion characteristics.A conclusive cause for the reported patient effect of intimal dissection, and the relationship to the product, if any, cannot be determined.There is no indication of a product quality issue with respect to the design, manufacture, or labeling.

• 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: 10168565
• MDR Text Key: 195585385
• Report Number: 2024168-2020-05139
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 08717648154867
• UDI-Public: 08717648154867
• 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: 07/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/18/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2023
• Device Model Number: B1080-040
• Device Catalogue Number: B1080-040
• Device Lot Number: 00205G1
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 83 YR
• Patient Weight: 55