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

Catalog Number A2020-020

Device Problem Tear, Rip or Hole in Device Packaging (2385)

Patient Problem No Patient Involvement (2645)

Event Date 04/02/2018

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 before patient use, the armada packing was removed from the outer box without reported issue.Once brought into the procedure area, it was noticed that the packaging had a hole in it.The device sterility was questioned and the device was set aside ad not used in the patient.There was no patient involvement.There was no additional information provided regarding this device issue.

Manufacturer Narrative

(b)(4).Evaluation summary: a visual inspection was performed on the returned device.The reported balloon damage was confirmed.The damage to the pouch was not verified as the packaging was not returned.A review of the lot history record revealed no manufacturing nonconformities that would have contributed to this complaint.A query of the complaint database for the reported lot was performed and revealed no other incidents reported.The investigation determined the reported difficulties appear to be related to circumstances of the procedure.Based on the information reviewed, there is no indication of a product quality issue with respect to manufacture, design or labeling.

Event Description

Subsequent to the previously filed medwatch report, the additional information was obtained: reportedly, this was a busy case and following the procedure, the device was noted on the preparation table with a crimped balloon.It is unknown whether or not the device was used in the patient.

• 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: 7470609
• MDR Text Key: 106896092
• Report Number: 2024168-2018-03150
• 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: 05/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/27/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2021
• Device Catalogue Number: A2020-020
• Device Lot Number: 8021341
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 04/24/2018
• Date Manufacturer Received: 05/18/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1