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

Model Number	A2040-040
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/09/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is expected to be returned.It has not yet been received.A follow-up report will be submitted with all additional relevant information.
Event or Problem Description
It was reported that the procedure was to treat a moderately calcified, moderately tortuous, 90% stenosed lesion in the popliteal artery.A 4.0x40mm armada 14 percutaneous transluminal angioplasty (pta) catheter was prepared for use, advanced and positioned to pre-dilate the lesion.The balloon was inflated to nominal pressure, ruptured on the first inflation.Another armada pta 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
Visual, functional and scanning electron microscopy (sem) analysis were performed on the returned device.The reported balloon rupture was not confirmed; however, there was a tear observed through the inflation port on the inner member and a leak confirmed on the inner member.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 investigation determined that the reported balloon rupture and/or noted leak was due to a tear noted to the inner member.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
• MDR Report Key: 11606566
• Report Number: 2024168-2021-02668
• Device Sequence Number: 3160016
• Product Code: DQY
• UDI-Device Identifier: 08717648156137
• UDI-Public: 08717648156137
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/07/2021

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: 02/29/2024
• Device Model Number: A2040-040
• Device Catalogue Number: A2040-040
• Device Lot Number: 0091641
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/13/2021
• Initial Date Received by Manufacturer: 03/10/2021
• Supplement Date Received by Manufacturer: 06/29/2021
• Initial Report FDA Received Date: 04/01/2021
• Supplement Report FDA Received Date: 07/07/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1