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

Model Number B1070-060

Device Problems Difficult to Remove (1528); Deformation Due to Compressive Stress (2889)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/11/2020

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 to treat an unspecified lesion.During removal of a 7.0x60mm armada 35 resistance was noted with the introducer sheath and the shaft became kinked.Another armada was used to successfully complete the procedure.No adverse patient effects or clinically significant delay.No additional information was provided.

Manufacturer Narrative

Visual analysis was performed on the returned device.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.The resistance and difficulty removing could not be confirmed due to the condition of the returned unit.The kink was not confirmed.The investigation determined that the reported difficulties were likely due to case related circumstances.The ruptured material and separation noted on the returned unit likely occurred as the balloon material was being pulled through the introducer sheath against resistance.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

Event Description

It was reported that the procedure was to treat an unspecified lesion.During removal of a 7.0x60mm armada 35 resistance was noted with the introducer sheath and the shaft became kinked.Another armada was used to successfully complete the procedure.No adverse patient effects or clinically significant delay.Device analysis of the returned device noted the balloon was separated and at the same location a rupture was also noted.The inner member was separated 5mm distal to the proximal seal.The account couldn't confirm the rupture or separation; however, it was confirmed nothing was left in the anatomy; the missing portion was discarded.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: 9786217
• MDR Text Key: 181976913
• Report Number: 2024168-2020-01985
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 08717648154799
• UDI-Public: 08717648154799
• 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: 04/15/2020

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: 05/31/2023
• Device Model Number: B1070-060
• Device Catalogue Number: B1070-060
• Device Lot Number: 91209G2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/13/2020
• Initial Date Manufacturer Received: 02/11/2020
• Initial Date FDA Received: 03/04/2020
• Supplement Dates Manufacturer Received: 04/02/2020
• Supplement Dates FDA Received: 04/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1