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

Catalog Number 1013465-100

Device Problems Device Difficult to Setup or Prepare (1487); Material Rupture (1546)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/17/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4). During processing of this complaint, attempts were made to obtain complete event, patient and device information. Evaluation summary: visual and functional inspection was performed on the returned device. The reported failure to flush was confirmed due to a pinhole in the balloon. It is likely that the balloon rupture is the result of interaction with anatomy or associated devices causing damage to the outer surface of the balloon. 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 revealed no other incidents. The investigation determined the reported difficulties appear to be related to circumstances of the procedure. There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

Event Description

It was reported that the procedure was to treat a lesion in the anterior tibial artery. The 3. 0x100mmx150cm armada 18 balloon dilatation catheter (bdc) was advanced to the target lesion for pre-dilatation and was used without issue. The armada bdc was removed without issue, however when an attempt was made to flush the bdc to reuse it again, the armada bdc could not be flushed. Another bdc was used to complete the procedure. There were no adverse patient effects and no reported clinically significant delay in the procedure. Returned device analysis identified fluid was observed coming out from a pinhole in the balloon. 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
• 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: 7527072
• MDR Text Key: 108807115
• Report Number: 2024168-2018-03723
• 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

• Remedial Action: Other
• Type of Report: Initial
• Report Date: 05/18/2018

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 05/18/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 01/31/2021
• Device Catalogue Number: 1013465-100
• Device Lot Number: 7081441
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/03/2018
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 05/08/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial