MAUDE Adverse Event Report: ABBOTT VASCULAR ARMADA 18 PTA CATHETER; PERIPHERAL DILATATION CATHETER

Model Number 1013466-020

Device Problem Difficult to Remove (1528)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/24/2019

Event Type  malfunction  

Manufacturer Narrative

The command 18 referenced is filed under a separate medwatch report number.Exemption number (b)(4) permits numbering sequence to begin with 10000, to avoid duplication of report numbers due to process transition.There may be gaps in numbering for reports submitted during the transition period.The device was received.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.Na.

Event Description

It was reported that the procedure was performed to treat a mildly calcified, mildly tortuous anterior tibial artery.There was resistance while attempting to remove the 4.0 x 20 mm armada 18 balloon dilatation catheter (bdc) over the command 18 guide wire.Both devices were removed as a single unit.After removal, it was noted that the guide wire polymer was torn at the tip.A new unspecified guide wire and a new unspecified bdc were used to successfully complete the procedure.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

Exemption number e2019001-permits numbering sequence to begin with 10000, to avoid duplication of report numbers due to process transition.There may be gaps in numbering for reports submitted during the transition period.A visual, dimensional and functional inspections were performed on the returned device and the reported difficulty to remove the guide wire 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 similar incidents reported from this lot.The investigation determined the reported difficulty to remove the guide wire appears to be related to circumstances of the procedure.It is likely that during advancement through the mildly calcified, mildly tortuous anatomy the guide wire was damaged or compromised causing resistance while advancing the balloon catheter over the wire.During retraction, the damaged polymer likely caused the difficulty to remove the wire.Manipulation against resistance likely caused the subsequent damages to the guide wire.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.Mfr site - contact office first and last name was updated from (b)(6).

Event Description

It was reported that the procedure was performed to treat a mildly calcified, mildly tortuous anterior tibial artery.There was resistance while attempting to remove the 4.0x20mm armada 18 balloon dilatation catheter (bdc) over the command 18 guide wire.Both devices were removed as a single unit.After removal, it was noted that the guide wire polymer was torn at the tip.A new unspecified guide wire and a new unspecified bdc were used to successfully complete the procedure.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.

• Brand Name: ARMADA 18 PTA CATHETER
• Type of Device: PERIPHERAL DILATATION CATHETER
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 8888375
• MDR Text Key: 154267733
• Report Number: 2024168-2019-10801
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 08717648207945
• UDI-Public: 08717648207945
• 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
• Type of Report: Initial,Followup
• Report Date: 09/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/13/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2021
• Device Model Number: 1013466-020
• Device Catalogue Number: 1013466-020
• Device Lot Number: 8052841
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/30/2019
• Date Manufacturer Received: 09/09/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: COMMAND 18
• Patient Age: 86 YR
• Patient Weight: 75