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

Model Number	B2050-040
Medical Device Problem Codes	Inflation Problem (1310); Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/12/2019
Type of Reportable Event	Malfunction
Additional 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.The device is expected to be returned for investigation.It has not yet been received.A follow-up report will be submitted with all additional relevant information.
Event or Problem Description
It was reported that the procedure was to treat a lesion in the mildly calcified, mildly tortuous superficial femoral artery (sfa).Reportedly, all steps for preparation of the 5 x 40 mm armada 35 percutaneous transluminal angioplasty (pta) catheter were performed per the instructions for use.The catheter was advanced to the lesion and positioned; however, the balloon would not inflate and a leak was noted at the hub.The device was removed and a 5 x 60 mm armada 35 pta catheter was used to complete the procedure.There were no adverse patient effects and there was no clinically significant delay in the procedure.No additional information was provided.
Additional Manufacturer Narrative
Exemption number e2019001.Visual and functional inspection was performed on the returned device.The reported inflation issue and leak 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 of the reported lot revealed no other incidents.The investigation determined the reported inflation issue and leak appear to be related to a potential product quality issue.The issue is being addressed per internal operating procedures.Abbott vascular will continue to trend the performance of these devices.Na.
Additional Manufacturer Narrative
Visual and functional inspection was performed on the returned device.The reported inflation issue and leak 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 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.

• 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: 9136752
• Report Number: 2024168-2019-12232
• Device Sequence Number: 11436502
• Product Code: LIT
• UDI-Device Identifier: 08717648155178
• UDI-Public: 08717648155178
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K111899
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• 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: 06/30/2022
• Device Model Number: B2050-040
• Device Catalogue Number: B2050-040
• Device Lot Number: 90123G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/19/2019
• Initial Date Received by Manufacturer: 09/10/2019
• Supplement Date Received by Manufacturer: 01/02/2020; 03/09/2020
• Initial Report FDA Received Date: 09/30/2019
• Supplement Report FDA Received Date: 01/15/2020; 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 Age: 67 YR
• Patient Weight: 77