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

Catalog Number B1100-020

Device Problems Difficult to Remove (1528); Deformation Due to Compressive Stress (2889)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/23/2018

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 additional relevant information.

Event Description

It was reported that the procedure was to treat the left superficial femoral artery. A 10 x 20 mm armada 35 balloon dilatation catheter (bdc) was used; however, the device met resistance with an unspecified guide wire during removal. Therefore, the bdc was removed independently using some extra force. When it was removed, it was noted that the tip was kinked. There were no adverse patient effects and no clinically significant delay in the procedure. No additional information was provided.

Manufacturer Narrative

(b)(4). Visual, dimensional and functional inspections were performed on the returned device. The reported kinked tip and difficulty to remove were unable to be confirmed as the proxy guide wire was advanced and removed without any issues or kinks noted. 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 identified no other similar incidents reported from this lot. The investigation was unable to determine a conclusive cause for the reported difficulties. There is no indication of a product quality issue with respect to manufacture, design or labeling.

• 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: 8055956
• MDR Text Key: 127274842
• Report Number: 2024168-2018-08646
• 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,distri
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 12/04/2018

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 11/09/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 10/31/2019
• Device Catalogue Number: B1100-020
• Device Lot Number: 60523G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/15/2018

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 11/26/2018
• Is This a Reprocessed and Reused Single-Use Device?: No