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

Catalog Number UNK ARMADA 35 OTW LL

Device Problems Deflation Problem (1149); Inflation Problem (1310); Patient-Device Incompatibility (2682)

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

Event Date 11/18/2022

Event Type  malfunction  

Manufacturer Narrative

B3: date of event ¿ estimated d4: the unique device identifier (udi) is unknown because the part number and lot number were not provided.The devices were not returned to abbott vascular for analysis.A review of the electronic lot history records (elhr), corrective action tracking system for the web (catsweb) database review and similar incident query for this product was not performed because the part/lot numbers were not reported.The investigation was unable to determine a conclusive cause for the reported inflation problem, deflation problem, and patient-device incompatibility.There is no indication of a product quality issue with respect to manufacture, design, or labeling.Attachment: rpt2135004 rev b titled; post market clinical follow-up evaluation report peripheral dilatation catheter family please see attachment for complete details.As multiple devices were captured in the pmcf report, the other devices referenced in the pmcf are filed under separate report numbersna.

Event Description

It was reported through a post market clinical follow up (pmcf) evaluation report identifying the armada 35 ll dilatation catheter that may be related to the following: adverse effects of dissection, perforation, embolism, occlusion/abrupt closure, pseudoaneurysm, and device issues of inflation and deflation issues, and inability to post-dilate a stent.Details are listed in the attached pmcf, titled post market clinical follow-up evaluation report peripheral dilatation catheter family please see the attached post market clinical follow up evaluation report for specific information.

• Brand Name: ARMADA 35 PTA CATHETER
• Type of Device: PERIPHERAL DILATATION CATHETER
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• Manufacturer (Section G): ABBOTT VASCULAR COSTA RICA, REG # 3009564766; 52 calle 3 b31 coyol free zone; el coyol alajuela ; CS
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 16801782
• MDR Text Key: 313943188
• Report Number: 2024168-2023-04272
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: K111899
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/24/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK ARMADA 35 OTW LL
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/29/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1