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

Model Number	B2060-100
Medical Device Problem Codes	Leak/Splash (1354); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/18/2021
Type of Reportable Event	Malfunction
Additional 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 or Problem 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
• Common Device Name: PERIPHERAL DILATATION CATHETER
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 11963122
• Report Number: 2024168-2021-04811
• Device Sequence Number: 3173352
• Product Code: LIT
• UDI-Device Identifier: 08717648155291
• UDI-Public: 08717648155291
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K111899
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/08/2021

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
• Operator of Device: Health Professional
• Device Model Number: B2060-100
• Device Catalogue Number: B2060-100
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/19/2021
• Initial Report FDA Received Date: 06/08/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1