MAUDE Adverse Event Report: ABBOTT VASCULAR ARMADA 18 PTA CATHETER; PERIPHERAL DILATATION CATHETER

Catalog Number UNK ARMADA 18 OTW

Device Problem Defective Device (2588)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/01/2019

Event Type  malfunction  

Manufacturer Narrative

Exemption number (b)(4).Permits numbering sequence to begin with 10000, to avoid duplication of report numbers due to process transition.There may be gaps in numbering for reports submitted during the transition period.The device is not returning for analysis.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Event Description

It was reported as a general comment that the armada 18 balloon appears longer than expected.The physician stated this as a general comment and reportedly, additional details such as number of procedures, devices, part/lot, and patient information was not available.No additional information was provided.

Manufacturer Narrative

Date of event: estimated.Exemption number (b)(4)-permits numbering sequence to begin with 10000, to avoid duplication of report numbers due to process transition.There may be gaps in numbering for reports submitted during the transition period.The device was not returned for evaluation.The lot history record (lhr) for this product could not be reviewed and a similar incident query could not be performed because the product was not returned for evaluation and the part and lot numbers were not reported.Based on the information provided, a conclusive cause could not be determined.Per the armada 18 product specification, the workable balloon length measured from distal balloon shoulder to proximal balloon shoulder with balloon inflated to nominal pressure (np) for the 80 mm balloon has a tolerance of -5mm/+3mm.It may be possible that the balloon in question was at the higher end of the specification and therefore appeared oversized; 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 18 PTA CATHETER
• Type of Device: PERIPHERAL DILATATION CATHETER
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 8922392
• MDR Text Key: 161718370
• Report Number: 2024168-2019-11071
• 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
• Type of Report: Initial,Followup
• Report Date: 09/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/22/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK ARMADA 18 OTW
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/23/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1