MAUDE Adverse Event Report: AV-TEMECULA-CT ARMADA 35 PTA CATHETER; PERIPHERAL DILATATION CATHETER

Catalog Number B1060-060

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/05/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device is expected to be returned for evaluation.It has not yet been received.A follow up report will be submitted with all relevant information.

Event Description

It was reported that the procedure was performed to treat an occluded and calcified lesion in a straight, short segment of the left superficial femoral artery (sfa).A 6.0x60mm armada 35 percutaneous transluminal angioplasty (pta) catheter was advanced to the target lesion with slight resistance.The pta catheter was pressurized; however, the balloon did not inflate beyond 2 atmospheres and contrast was seen flowing out of a possible hole in the balloon.The pta catheter was removed from the patient, and the procedure was completed with an unspecified device.There was no adverse patient effect and no reported clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

Internal file number - (b)(4).Evaluation summary: visual inspection was performed on the returned device.The reported balloon rupture was confirmed.The resistance was unable to be confirmed as it was based on case circumstances.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 during advancement and balloon rupture was likely due to interaction with the moderately calcified and occluded lesion resulting in damage to the outer surface of the balloon material as was noted with the multiple scratches observed on the returned unit.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
• Type of Device: PERIPHERAL DILATATION CATHETER
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• MDR Report Key: 8184666
• MDR Text Key: 131378742
• Report Number: 2024168-2018-09925
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• PMA/PMN Number: K111899
• 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: 01/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2018
• 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: B1060-060
• Device Lot Number: 80621G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/04/2019
• Date Manufacturer Received: 01/16/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1