MAUDE Adverse Event Report: ABBOTT VASCULAR ARMADA 14 PTA CATHETER; PERIPHERAL DILATATION CATHETER

Catalog Number	A2030-200
Medical Device Problem Code	Deflation Problem (1149)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/06/2019
Type of Reportable Event	Malfunction
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 received.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Event or Problem Description
It was reported that the procedure was performed to treat a calcified lesion in the right superficial femoral artery.Following atherectomy and balloon angioplasty with unspecified balloon catheters, a 3.0 x 200 mm armada 14 percutaneous transluminal angioplasty (pta) balloon catheter was advanced to the lesion with no reported resistance.The balloon of the pta balloon catheter was inflated once to nominal pressure; however, failed to deflate.The unspecified indeflator was switched to a syringe and the balloon was fully deflated.On removal of the balloon with no reported resistance, a further inflation was made at the proximal lesion.While there was no reported issue with inflation, the balloon failed to deflate again.The balloon was successfully deflated with the use of a syringe.The pta balloon catheter was removed and no further intervention was reported.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.
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.Visual and functional analysis was performed on the returned device.The reported deflation issue was not confirmed as the device inflated and deflated as expected.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 identified no other incidents and/or complaints.The investigation was unable to determine a cause for the reported deflation issue.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

• Brand Name: ARMADA 14 PTA CATHETER
• Common Device Name: PERIPHERAL DILATATION CATHETER
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 8936594
• Report Number: 2024168-2019-11205
• Device Sequence Number: 13578735
• Product Code: DQY
• UDI-Device Identifier: 08717648156113
• UDI-Public: 08717648156113
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K102705
• 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
• Report Date (Section B): 09/12/2019

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 Expiration Date: 08/31/2022
• Device Catalogue Number: A2030-200
• Device Lot Number: 9032941
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/13/2019
• Initial Date Received by Manufacturer: 08/06/2019
• Supplement Date Received by Manufacturer: 09/09/2019
• Initial Report FDA Received Date: 08/27/2019
• Supplement Report FDA Received Date: 09/12/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 77 YR
• Patient Weight: 92