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

Catalog Number 1013468-040

Device Problem Unsealed Device Packaging (1444)

Patient Problem No Patient Involvement (2645)

Event Date 06/19/2018

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 is expected to be returned for evaluation. It has not yet been received. A follow up report will be submitted with all relevant information.

Event Description

It was reported that during unpacking of a 5. 0 x 40 mm armada 18 balloon catheter, prior to opening the pouch it was observed that the seal was incomplete. A corner of the pouch was not sealed and a decision was made to not use the balloon catheter. The procedure was successfully completed with an unspecified armada balloon catheter. There was no patient involvement and no clinically significant delay in the procedure. No additional information was provided.

Manufacturer Narrative

(b)(4). Visual inspection was performed on the returned product pouch. The reported unpackaged device packaging and sterility breach was confirmed. A review of the lot history record identified no manufacturing nonconformities issued to the reported lot and relabeled lot that could have contributed to this event. Additionally, a review of the complaint history revealed no other similar incidents reported for this lot. The investigation was unable to determine a conclusive cause for the reported unpackaged device packaging and sterility breach. There is no indication of a product quality issue with respect to 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
• MDR Report Key: 7675924
• MDR Text Key: 113626258
• Report Number: 2024168-2018-05228
• 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,health
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 08/15/2018

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 07/10/2018
• 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: 1013468-040
• Device Lot Number: 7080141
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/26/2018

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 08/14/2018
• Is This a Reprocessed and Reused Single-Use Device?: No