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

Catalog Number	A2040-060
Medical Device Problem Codes	Deflation Problem (1149); Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/25/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.The device is expected to be returned for investigation.It has not yet been received.A follow-up report will be submitted with all additional relevant information.Na.
Event or Problem Description
It was reported that this was a procedure performed to treat a chronic total occlusion in the superficial femoral artery.The armada 14 dilatation catheter was inflated without issue; however, the balloon only partially deflated, but was able to be pulled back into the sheath and removed without issue.The patient was observed for approximately 2 hours post procedure and no patient injury was noted.A second armada 14 was used without issue.No additional information was provided.
Additional Manufacturer Narrative
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.Visual and functional analysis was performed on the returned device.The reported deflation issue was unable to be confirmed due to the condition of the returned device.The separation was 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 incidents and/or complaints.The investigation was unable to determine a cause for the reported deflation issue.The separation likely occurred while pulling the catheter back into the introducer sheath with the balloon still partially inflated.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.Mfr site- contact office name.
Event or Problem Description
Subsequent to the initial 30-day medwatch report, the following information was received: during removal of the armada 14 dilatation catheter, the balloon portion of the device separated.The separated portion was removed and no portion of the device remains in the anatomy.No additional information was provided.

• 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: 8843506
• Report Number: 2024168-2019-10460
• Device Sequence Number: 262464
• Product Code: DQY
• UDI-Device Identifier: 08717648156144
• UDI-Public: 08717648156144
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K102705
• 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): 09/09/2019

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: 04/30/2022
• Device Catalogue Number: A2040-060
• Device Lot Number: 8112741
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/31/2019
• Initial Date Received by Manufacturer: 07/08/2019
• Supplement Date Received by Manufacturer: 09/05/2019
• Initial Report FDA Received Date: 07/30/2019
• Supplement Report FDA Received Date: 09/09/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1