MAUDE Adverse Event Report: ABBOTT VASCULAR ARMADA 35 PTA CATHETER; PERIPHERAL DILATATION CATHETER

Model Number B1140-040

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

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/18/2021

Event Type  malfunction  

Manufacturer Narrative

The device was received.Investigation is not yet completed.A follow up report will be submitted with all additional relevant information.

Event Description

It was reported that a 14x40mm armada 35 balloon dilatation catheter (bdc) was returned to abbott vascular with the packaging torn; thus, sterility was breached.No additional information was provided.

Manufacturer Narrative

Visual analysis was performed on the returned device.The reported packaging damage was confirmed.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 identified no other complaints reported from this lot.Based on the reported information, a definitive cause for the packaging damage could not be determined.It may be possible that the damage occurred at the account or during transit to the account; however, this could not be confirmed.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

• Brand Name: ARMADA 35 PTA CATHETER
• Type of Device: PERIPHERAL DILATATION CATHETER
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 12147162
• MDR Text Key: 261253425
• Report Number: 2024168-2021-05903
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 08717648155024
• UDI-Public: 08717648155024
• Combination Product (y/n): N
• PMA/PMN Number: K111899
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 08/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/09/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: B1140-040
• Device Catalogue Number: B1140-040
• Device Lot Number: 10223G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/18/2021
• Date Manufacturer Received: 08/06/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1