MAUDE Adverse Event Report: ABBOTT VASCULAR ARMADA 14 PTA CATHETER; PERIPHERAL DILATATION CATHETER

Model Number	A2040-020
Medical Device Problem Codes	Off-Label Use (1494); Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is expected to be returned for evaluation.It has not yet been received.A follow up report will be submitted with all additional relevant information.(b)(4).
Event or Problem Description
It was reported the procedure was treat a heavily calcified, heavily tortuous unknown carotid artery.The 4.0x20mm armada 14 balloon dilatation catheter (bdc) was chosen for pre-dilatation since the vessel size of the lesion matched the size of the armada14 and there was no other balloon on site at that time to replace it.The bdc was flushed and the guide wire lumen was connected to the unspecified pressure pump lumen; however, the balloon ruptured at 8 atmospheres during the first inflation.Under radiography contrast leakage was observed.Another device was used to successfully complete the procedure.There was no adverse patient effects and clinically significant delay reported.No additional information was provided.
Additional Manufacturer Narrative
A visual, functional and scanning electron microscopy (sem) analysis were performed on the returned device.The reported material rupture was not 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 complaints reported from this lot.The sem was performed to analyze the damage to the inner member within the inflation port.The results suggest that the inner member failure may be attributed to mechanical damage.The edge of the leak exhibited mechanical damage and tearing.Although a definitive cause for the inner member damage could not be determined, there was no leak noted during preparation indicating that the damage was not pre-existing.Additionally, there are several factors to ensure that this type of damage does not occur during manufacturing.The inner member is inserted into the sidearm at the adaption bonding station and glued in place to seal the catheter.At no point post in this step is the proximal inner member processed at this location.The immediate station post adaption bond is a leak test station where all units are pressurized, and any damage or leak caused by manufacturing would be identified there and scrapped.The area of damage and sem reviews suggest an object was inserted into the inflation lumen.At no point during the manufacturing process is anything inserted into the inflation port.It should be noted that the percutaneous transluminal angioplasty (pta) catheter, armada 14, global, instructions for use states: the device is intended to dilate stenosis in femoral, popliteal, infra popliteal and real arteries and for the treatment of obstructive lesion of native or synthetic arteriovenous dialysis fistulae.It could not be determined if using the armada 14 off-label to treat the heavily calcified, heavily tortuous unknown carotid artery caused or contributed to the reported/noted difficulties.The investigation could not confirm the reported material rupture; however, a leak and inner member tear were noted during return evaluation of the device.It is likely the noted leak and inner member tear were misidentified as the reported material rupture.Although a cause for the tear could not be determined, there was no leak noted during preparation for use indicating that the damage was not pre-existing.Additionally, based on the evaluation of the returned unit and sem analysis, the inner member damage may be attributed to mechanical damage and may suggest that an object was inserted into the inflation port; however, this could not be confirmed.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

• Brand Name: ARMADA 14 PTA CATHETER
• Common Device Name: PERIPHERAL DILATATION CATHETER
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• Manufacturer (Section G): ABBOTT VASCULAR, REG # 3005718570 (P099); cashel road; clonmel tipperary ; EI
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 12835984
• Report Number: 2024168-2021-10550
• Device Sequence Number: 4561023
• Product Code: DQY
• UDI-Device Identifier: 08717648156120
• UDI-Public: 08717648156120
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K102705
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 02/11/2022

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: 02/29/2024
• Device Model Number: A2040-020
• Device Catalogue Number: A2040-020
• Device Lot Number: 0090941
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/21/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/01/2021
• Supplement Date Received by Manufacturer: 02/07/2022
• Initial Report FDA Received Date: 11/18/2021
• Supplement Report FDA Received Date: 02/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/09/2020
• 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 Sex: Unknown