MAUDE Adverse Event Report: AV-TEMECULA-CT ARMADA 14 XT PTA CATHETER; PERIPHERAL DILATATION CATHETER

Catalog Number F2020-020

Device Problems Material Rupture (1546); Improper or Incorrect Procedure or Method (2017); Difficult to Advance (2920)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/27/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.(b)(4).It is unknown if the device is returning.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.The other armada 14 xt device referenced is being filed under a separate medwatch mfr number.

Event Description

It was reported that during a procedure to treat a heavily calcified coronary artery, two armada 14 xt percutaneous transluminal angioplasty (pta) balloons were inflated above rated burst pressure (rbp) and ruptured.There were no reported adverse patient effects and there was no reported clinically significant delay in the procedure.No additional information was provided.

Event Description

Subsequent to the previously filed report, the following additional information was received: a 2.0x20mm armada 14 xt and 1.5x40mm armada 14 balloon catheter met resistance with the patient anatomy during advancement prior to the balloon ruptures.The procedure was successfully completed with two new armada 14 balloon catheters.No additional information was provided.

Manufacturer Narrative

Device codes: 2920 labeled.(b)(4).Correction: manufacturing site.Correction: device return status.The device was discarded and is not available for evaluation.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 similar incidents.Based on the information provided, the reported balloon rupture appears to be user related.The balloon was inflated above rated burst pressure (rbp) and ruptured.It should be noted that the armada 14xt instructions for use states: balloon pressure should not exceed the rbp.The resistance during advancement was likely due to anatomical conditions.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

• Brand Name: ARMADA 14 XT 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: 8075873
• MDR Text Key: 128046259
• Report Number: 2024168-2018-08849
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• PMA/PMN Number: K102705
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 01/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2018
• Device Catalogue Number: F2020-020
• Device Lot Number: 51021G1
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/17/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1