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

Model Number B2060-100

Device Problems Leak/Splash (1354); Material Split, Cut or Torn (4008)

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

Event Date 05/18/2021

Event Type  malfunction  

Manufacturer Narrative

The device expiration and manufacturing dates could not be provided as the device lot number was not provided and the device was not returned.The device was not returned for analysis.A lot history search and similar incident query could not be conducted as the lot number was not provided.The investigation was unable to determine a conclusive cause for the reported difficulties.It may be possible that the balloon became damaged during removal of the protective sheath or due to interaction with associated devices during preparation; however, this could not be confirmed as the device was not returned and as reported the exact location of the suspect hole is not known.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 on (b)(6) 2021, during device preparation, the armada catheter (b2060-100, unk lot) was being prepped per instructions for use when the catheter would not hold pressure and would pull/leak air.The operator suspected a hole somewhere along the device although the exact location was not known.The device was discarded and not used.There was no patient involvement.No additional information was provided regarding this device issue.

• 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: 11963122
• MDR Text Key: 263614184
• Report Number: 2024168-2021-04811
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 08717648155291
• UDI-Public: 08717648155291
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K111899
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/08/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: B2060-100
• Device Catalogue Number: B2060-100
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/19/2021
• 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