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

Catalog Number B2050-020

Device Problems Deflation Problem (1149); Inflation Problem (1310); Unintended System Motion (1430); Difficult to Remove (1528)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/22/2018

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 was received.Investigation is not yet complete.A follow up report will be submitted with all relevant information.

Event Description

It was reported that the procedure was performed to treat an 80% stenosed, moderately tortuous, mildly calcified, de novo lesion in the mid femoral artery.A 5x20mm x 135cm armada 35 percutaneous transluminal angioplasty (pta) catheter was placed in the target lesion and the device was inflated to 6 atmospheres.The inflation device gauge revealed that the pressure was increasing; however, the balloon did not initially inflate.Shortly thereafter, the balloon suddenly inflated and was moved distally through the lesion, but was unable to deflate with the inflation device by holding negative for approximately one minute to remove the saline contrast media.The fully inflated pta balloon was pulled, with resistance, through the target lesion and femoral artery to the sheath in the common iliac.Upon touching the distal sheath tip, the balloon suddenly deflated and the entire device was completely withdrawn from patient anatomy through the sheath without any intervention.Unspecified devices were used to perform balloon angioplasty and stenting of the target lesion to complete the procedure.There was no adverse patient effect and no reported clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

(b)(4).Evaluation summary: visual and functional analysis was performed on the returned device.The reported deflation issue was not 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 revealed no other incidents.The investigation was unable to determine a conclusive cause for the reported difficulties.It may be possible that the inflation lumen was blocked due to the shaft being bent or entrapped within the anatomy during use; however, this could not be confirmed.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: 8165930
• MDR Text Key: 130478139
• Report Number: 2024168-2018-09714
• 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: 01/04/2019

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: 10/31/2019
• Device Catalogue Number: B2050-020
• Device Lot Number: 60507G1
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 12/13/2018
• Initial Date Manufacturer Received: 11/27/2018
• Initial Date FDA Received: 12/14/2018
• Supplement Dates Manufacturer Received: 12/27/2018
• Supplement Dates FDA Received: 01/04/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1