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

Device Problem Entrapment of Device (1212)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/03/2018

Event Type  Injury  

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.The ht command guide wire is filed under a separate manufacturing report number.

Event Description

It was reported that this was a percutaneous intervention treating the popliteal artery.During advancement of the armada 18 unto the command ht guide wire, the armada stuck to the wire.As to not lose access, both the ht command and armada dilatation catheter were advanced to the popliteal artery.The balloon was attempted to be cut and peeled off the wire using a scalpel.One third of the balloon was retrieved from the groin access point and the rest two third of the balloon was retrieve below the shin access point.There was no surgical intervention to remove the device.The case took 20-40 minutes longer due to this issue; however, there was no clinical significance due to this issue reported.The patient is in "good" condition.No additional information was provided regarding this issue.

Manufacturer Narrative

(b)(4).The unique device identifier (udi) cannot be provided as the part and lot numbers were not reported.Visual inspections were performed on the returned device.The reported entrapment of the device or difficult to position over the guide wire was unable to be confirmed due to the returned condition of the device.A review of the electronic lot history and similar incident query for this product was not performed since the part and lot numbers were not reported.The investigation was unable to determine a conclusive cause for the reported difficulties since only a portion of the balloon was the returned.The treatment appears to be related to circumstances of the procedure since the balloon was cut and peeled off the wire using a scalpel.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): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• MDR Report Key: 7720978
• MDR Text Key: 115061812
• Report Number: 2024168-2018-05775
• 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: 08/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/25/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/20/2018
• Date Manufacturer Received: 08/23/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 4F-SHEATHHT COMMAND GUIDE WIRE
• Patient Outcome(s): Required Intervention
• Patient Age: 62 YR