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

Model Number	B2040-080
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/12/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Exemption number e2019001.The device will not be returned for evaluation, the device was reportedly discarded.Investigation is not yet complete.A follow-up report will be submitted with all.Additional relevant information.Na.
Event or Problem Description
It was reported that the procedure was to treat an av fistula in the left arm.The 4.0x80mm armada 35 balloon dilatation catheter was advanced to the lesion and inflated to 8 atmospheres (atm) when a leak was noted coming from the strain relief below the sidearm.The device was removed without issue and the procedure completed with a new device.There was no clinically significant delay in the procedure and no adverse patient effects.No additional information was provided.
Additional Manufacturer Narrative
The device was not returned for analysis.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 of the reported lot revealed no other incidents.The investigation has determined that the reported leak is not related to a potential product quality issue as the occurrence rate is within the acceptable range of the risk assessment.H6: results code 170 removed, conclusion code 23 removed.H10: additional manufacturer narrative updated.
Additional Manufacturer Narrative
G9: 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.The device was not returned for analysis.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 of the reported lot revealed no other incidents.The investigation determined the reported hub leak appears to be related to a potential product quality issue.The issue is being addressed per internal operation procedures.Abbott vascular will continue to trend the performance of these devices.

• 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: 9538158
• Report Number: 2024168-2020-00003
• Device Sequence Number: 2407903
• Product Code: LIT
• UDI-Device Identifier: 08717648155109
• UDI-Public: 08717648155109
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K111899
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/30/2022
• Device Model Number: B2040-080
• Device Catalogue Number: B2040-080
• Device Lot Number: 90624G1
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/12/2019
• Supplement Date Received by Manufacturer: 01/03/2020; 03/09/2020
• Initial Report FDA Received Date: 01/02/2020
• Supplement Report FDA Received Date: 01/10/2020; 03/09/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 88