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

Catalog Number 1013468-080

Device Problems Detachment Of Device Component (1104); Difficult To Position (1467); Difficult to Remove (1528)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/05/2015

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 steelcore guide wire device referenced is filed under a separate medwatch report.

Event Description

It was reported that the patient underwent a peripheral procedure to treat in-stent restenosis of an unspecified stent implanted in the right superficial femoral artery.A steelcore guide wire was advanced to the target lesion.A 2.0 laser was advanced and debulked the restenosis.An attempt was made to load the 5.0 x 80 mm armada dilatation catheter onto the guide wire; however, it became stuck.Attempts were made to remove the armada and the armada dilatation catheter separated outside the patient anatomy.The guide wire was in the patient anatomy, but the armada had not yet entered the anatomy.The steelcore guide wire and armada were removed from the patient anatomy as a single unit.A spartacore guide wire was then used with a new armada dilatation catheter without issue.There was no adverse patient effect and no clinically significant delay.No additional information was provided.

Manufacturer Narrative

(b)(4).Evaluation summary: the device was returned and the reported resistance, separation and difficulty removing was confirmed.Based on visual dimensional and functional analysis of the returned device, there is no indication of a product quality issue with respect to manufacture, design or labeling.The reported difficulties appear to be due to case circumstances.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 handling database revealed no other similar incidents reported from this lot.Based on the reviewed information, there is no indication the issue was caused by or related 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
• Manufacturer (Section G): CLONMEL, IRELAND REG# 9616693; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• Manufacturer Contact: connie speck ; abbott vascular; 26531 ynez road; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 5255093
• MDR Text Key: 32411637
• Report Number: 2024168-2015-07153
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K151317
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 01/12/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2018
• Device Catalogue Number: 1013468-080
• Device Lot Number: 5070941
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 11/10/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/07/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 73 YR
• Patient Weight: 111