MAUDE Adverse Event Report: AV-TEMECULA-CT ARMADA 18 PTA CATHETER; PERIPHERAL DILATATION CATHETER

Catalog Number 1013464-200

Device Problems Material Rupture (1546); Difficult to Advance (2920)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/04/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.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.The additional armada device referenced is being filed under a separate medwatch report.

Event Description

It was reported that the procedure was to treat a heavily calcified lesion in the non tortuous posterior tibial artery.An armada 14 percutaneous transluminal angioplasty (pta) catheter was advanced with slight resistance noted with the anatomy.The catheter was inflated to 8 atmospheres and ruptured during the first inflation.There was no resistance noted during removal of the catheter.An armada 18 pta catheter was advanced with slight resistance noted with the anatomy.The catheter was inflated to 8 atmospheres and ruptured during the first inflation.There was no resistance noted during removal of the catheter.A non-abbott device was used to complete the procedure.There were no adverse patient effects and there was no reported clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

Internal file number - (b)(4).Correction: the device was initially reported as returning for analysis, but has now been reported as not returning because it was discarded at the account.The device was not returned for analysis.A review of the lot history record revealed no manufacturing nonconformities that would have contributed to this complaint.Additionally, a review of the complaint history of the reported lot revealed no other incidents.Based on the information provided, the reported difficulties appear to be due to operational circumstances of the procedure.It is likely that the resistance noted during advancement and balloon rupture were due to interaction with lesion site which was described as heavily calcified.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

• Brand Name: ARMADA 18 PTA CATHETER
• Type of Device: PERIPHERAL DILATATION CATHETER
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• MDR Report Key: 8181898
• MDR Text Key: 130976023
• Report Number: 2024168-2018-09898
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• PMA/PMN Number: K151317
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 01/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2021
• Device Catalogue Number: 1013464-200
• Device Lot Number: 8061341
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1