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

Catalog Number 1014260-040

Device Problems Leak/Splash (1354); Product Quality Problem (1506); Material Split, Cut or Torn (4008)

Patient Problems No Consequences Or Impact To Patient (2199); No Patient Involvement (2645)

Event Date 09/17/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4). During processing of this complaint, attempts were made to obtain complete event, patient and device information. Date of event - estimate. It is unknown if the device is returning. Investigation is not yet complete. A follow-up report will be submitted with all additional relevant information.

Event Description

It was reported that there was a leak at the shaft of a 5. 0 x 40 mm armada 18 percutaneous transluminal angioplasty (pta) balloon catheter. There were no reported adverse patient effects. No additional information was provided.

Manufacturer Narrative

(b)(4). Visual and functional inspection was performed on the returned device. The reported leak was confirmed. The tear in the shaft or irregular appearance 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. The investigation determined that the leak appears to be related to a potential product quality issue. The issue is being addressed per internal operating procedures. Av will continue to trend the performance of these devices.

Event Description

Subsequent to the initially filed report, the following information was received: the armada 18 percutaneous transluminal angioplasty (pta) balloon catheter was inadvertently reported as a 5. 0 x 40 mm balloon. The correct device is a 2. 5 x 40 mm armada 18 pta balloon catheter. The leak in the shaft of the pta balloon catheter was noted during an optical inspection of the device prior to use. The weld-seam was identified as not being fully closed by touch and on further inspection a hole was visible in the shaft. Saline was used for confirmation and was seen leaking from the hole. The device was not used and there was no patient involvement. A new armada 14 pta balloon catheter was used successfully to continue the procedure. There was no clinically significant delay in the procedure. No additional information was provided.

• 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: 7997074
• MDR Text Key: 124863546
• Report Number: 2024168-2018-08108
• 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: 11/30/2018

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 10/23/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 12/31/2019
• Device Catalogue Number: 1014260-040
• Device Lot Number: 6070741
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/26/2018

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 11/28/2018
• Is This a Reprocessed and Reused Single-Use Device?: No