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

Catalog Number	B1090-040
Medical Device Problem Codes	Difficult to Remove (1528); Material Rupture (1546); Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	06/19/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was received.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.G9: exemption number e2019001 permits numbering sequence to begin with 10000, to avoid duplication of report numbers due to process transition.There may be gaps in numbering for reports submitted during the transition period.Na.
Event or Problem Description
It was reported that during a balloon angioplasty procedure to treat a heavily calcified and non-tortuous lesion in an unspecified vessel.A 9.0x40mm armada balloon dilatation catheter (bdc) ruptured during the first inflation at 11 atmospheres.The balloon and tip separated from the shaft when attempted to be pulled back into the sheath.One of the radiopaque markers came out of the sheath when flushed out; however, the tip could not be located.It is unknown if the tip is lodged in the sheath or if it is inside the patient, the rest of the bdc was removed from the anatomy.A new sheath was inserted and another unspecified balloon was used to complete the procedure.Pedal pulses were checked and pulses were palpable.There was no clinically significant delay in the procedure and no adverse patient sequela.No additional information was provided.
Additional Manufacturer Narrative
Visual analysis was performed on the returned device.The reported balloon rupture and separation was confirmed.The difficulty removing was not tested due to 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 incidents.The investigation determined that the reported difficulties were likely due to case related circumstances.It is likely that the balloon interacted with the heavy lesion calcification causing damage to the outer surface of the balloon material which subsequently ruptured during inflation.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

• Brand Name: ARMADA 35 PTA CATHETER
• Common Device Name: PERIPHERAL DILATATION CATHETER
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 8783119
• Report Number: 2024168-2019-10044
• Device Sequence Number: 19499563
• Product Code: LIT
• UDI-Device Identifier: 08717648154904
• UDI-Public: 08717648154904
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K111899
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/30/2021
• Device Catalogue Number: B1090-040
• Device Lot Number: 80602G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/24/2019
• Initial Date Received by Manufacturer: 06/19/2019
• Supplement Date Received by Manufacturer: 07/24/2019
• Initial Report FDA Received Date: 07/11/2019
• Supplement Report FDA Received Date: 08/16/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 85 YR
• Patient Weight: 45