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

Model Number B1030-040

Device Problems Break (1069); Inflation Problem (1310); Material Separation (1562)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/29/2020

Event Type  malfunction  

Manufacturer Narrative

The device is expected to be returned for investigation.It has not yet been received.A follow-up report will be submitted with all additional relevant information.

Event Description

It was reported that the procedure was performed to treat an unspecified lesion.The 3.0x40mm armada 35 balloon could not be fully inflated as the hub was cracked at the inflation port threading.The balloon was used at nominal pressure as full angioplasty was not needed.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

A visual and functional inspection was performed on the returned device.The reported difficulties were unable to be confirmed as no cracks, or damages were noted on the hub and the device was able to inflate and hold pressure.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 incidents and/or complaints reported from this lot.The investigation was unable to determine a conclusive cause for the reported difficulties.There is no indication of a product quality issue with respect to manufacture, design or labeling.Na.

Event Description

It was reported that the procedure was performed to treat an unspecified lesion.The 3.0x40mm armada 35 balloon could not be fully inflated as the hub was cracked at the inflation port threading.The balloon was used at nominal pressure as full angioplasty was not needed.There were no adverse patient effects and no clinically significant delay in the procedure.Additional information received subsequent to filing the initial report: the inflation hub had a tiny piece of the plastic rim missing, resulting in an inadequate seal.No additional information was provided.

• 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: 10273040
• MDR Text Key: 199905963
• Report Number: 2024168-2020-05801
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 08717648154492
• UDI-Public: 08717648154492
• Combination Product (y/n): N
• PMA/PMN Number: K111899
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 08/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2022
• Device Model Number: B1030-040
• Device Catalogue Number: B1030-040
• Device Lot Number: 90718G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/23/2020
• Initial Date Manufacturer Received: 06/29/2020
• Initial Date FDA Received: 07/14/2020
• Supplement Dates Manufacturer Received: 08/04/2020
• Supplement Dates FDA Received: 08/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 66 YR