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

Catalog Number 1014254-080

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/07/2019

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 was received.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.The other armada referenced is filed under a separate medwatch report.

Event Description

It was reported that the procedure was to treat a de novo lesion located in the mid tibial artery that was mildly tortuous, heavily calcified and 90% stenosed.The first armada balloon was advanced to the lesion with slight resistance and during the first inflation at 6 atmospheres, it ruptured.A second armada was advance to the lesion with slight resistance and during the first inflation at 8 atmospheres, it ruptured.A non-abbott balloon was used to complete the procedure.There was no reported adverse patient effect or a clinically significant delay in procedure.No additional information was provided.

Manufacturer Narrative

Internal file number - (b)(4).Evaluation summary: visual inspection was performed on the returned 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 revealed no other similar incidents.The investigation determined the reported difficulties appear to be related to circumstances of the procedure.It is likely that the reported resistance and balloon rupture is the result of interaction with the heavy calcified lesion.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

Event Description

Subsequent to the initial 30-day medwatch report, it was confirmed that both balloons ruptured during the first inflation; the first device at 6 atmospheres and the second at 8 atmospheres.There was friction during advancement caused by narrowing vessel.No additional information was provided.

• 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: 8656773
• MDR Text Key: 146680033
• Report Number: 2024168-2019-04254
• 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,foreig
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 06/21/2019

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
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2021
• Device Catalogue Number: 1014254-080
• Device Lot Number: 8071041
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 05/28/2019
• Initial Date Manufacturer Received: 05/07/2019
• Initial Date FDA Received: 05/30/2019
• Supplement Dates Manufacturer Received: 06/14/2019
• Supplement Dates FDA Received: 06/21/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1