MAUDE Adverse Event Report: AV-TEMECULA-CT ARMADA 14 PTA CATHETER PERIPHERAL DILATATION CATHETER

Catalog Number A2030-120

Device Problem Unsealed Device Packaging (1444)

Patient Problem No Patient Involvement (2645)

Event Date 05/11/2018

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 relevant information.

Event Description

It was reported that during unpacking of the device, a bubble was noted in the middle of the packaging seal on the pouch, the seal was not complete and open at the bubble. When opening the white flap on the pouch, it was easier than normal due to the unsealed portion. The device was set aside and not used. A new armada 14 was used to complete the procedure with no issue. There was no clinically significant delay in the procedure and no patient involvement. No additional information was provided.

Manufacturer Narrative

(b)(4). Evaluation summary: visual inspection was performed on the returned device. The cloudy appearance indicated evidence that the seal was previously intact. It is likely that the pouch was inadvertently opened and placed back into the inventory at the account. 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 of the reported lot revealed no other similar incidents. The investigation determined that the opened pouch was likely due to previous handling at the account. There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

• Brand Name: ARMADA 14 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: 7566273
• MDR Text Key: 110120784
• Report Number: 2024168-2018-04106
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• PMA/PMN Number: K102705
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 06/11/2018

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 06/04/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 07/31/2021
• Device Catalogue Number: A2030-120
• Device Lot Number: 8022641
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 05/30/2018

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 06/05/2018
• Is This a Reprocessed and Reused Single-Use Device?: No