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

Model Number B1070-080

Device Problem Difficult to Remove (1528)

Patient Problem Aneurysm (1708)

Event Date 01/15/2021

Event Type  Injury  

Manufacturer Narrative

The device will not be returned for evaluation as the device was reportedly discarded.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Event Description

It was reported that this was a procedure to treat thrombosis in the left arteriovenous (av) fistula.An armada balloon catheter was inserted, and angioplasty was performed.However, after angioplasty was performed, angiogram showed residual thrombus and an aneurysm of the av fistula.A high-grade stenosis of the av fistula was also noted.During removal of the balloon catheter, the physician stated that due to patient anatomy, the device was difficult to remove.The balloon catheter was able to be removed without causing damage to the patient.To further treat the stenosed area, a non-abbott device was successfully used.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

The device was not returned 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 similar incidents reported from this lot.The investigation determined that anatomical conditions were the likely cause for the reported difficulties to remove.The reported aneurysm is also caused by case circumstances.The reported patient effect of aneurysm as listed in the instructions for use, states: the following complications may occur as a result of percutaneous transluminal angioplasty (pta) but may not be limited to: aneurysm or pseudoaneurysm in vessel, or at vascular access site.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.Na.

Manufacturer Narrative

The device was returned for analysis.The reported difficulty to remove could not be tested based on the condition of the device.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 reported from this lot.The investigation determined that anatomical conditions were the likely cause for the reported difficulties to remove.The reported aneurysm is also caused by case circumstances.The reported patient effect of aneurysm is listed in the instructions for use as a potential procedural complication.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.D4: lot number updated from 01016g2 to 01016g1.D9: the device has been received.H6: type of investigation code 4114, removed.H6: type of investigation code 10, added.

• 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: 11308107
• MDR Text Key: 231169798
• Report Number: 2024168-2021-01061
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 08717648154805
• UDI-Public: 08717648154805
• 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,Followup
• Report Date: 04/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/10/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2024
• Device Model Number: B1070-080
• Device Catalogue Number: B1070-080
• Device Lot Number: 01016G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/23/2021
• Date Manufacturer Received: 04/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 83 YR
• Patient Weight: 55