MAUDE Adverse Event Report: AV-TEMECULA-CT ARMADA 18 PTA CATHETER; PERIPHERAL DILATATION CATHETER

Catalog Number	1013470-060
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/16/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Internal file number - (b)(4): during processing of this complaint, attempts were made to obtain complete event, patient and device information.The device was not returned for analysis.It may be possible that the inflation device used during the procedure was not properly connected to the hub; however, this could not be confirmed.A review of the lot history record revealed no manufacturing nonconformities that would have contributed to this complaint.Additionally, a review of the complaint history of the reported lot revealed no other incidents.Without having the device to examine, a conclusive cause for the leak could not be determined.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 the procedure was to treat a lesion located in the superficial femoral artery.No issues were noted during preparation of the 6.0mm/60mm armada 18 balloon catheter.The balloon catheter crossed the lesion with ease.During attempted inflation of the balloon a drop in pressure was noted.Upon investigation it was observed that the hub was leaking causing the loss of pressure.The balloon catheter was removed without issue from the patient.The procedure was ended.No adverse patient effects or clinically significant delay in the procedure were reported.No additional information was provided.
Additional Manufacturer Narrative
(b)(4).

• Brand Name: ARMADA 18 PTA CATHETER
• Common Device Name: PERIPHERAL DILATATION CATHETER
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• MDR Report Key: 6270814
• Report Number: 2024168-2017-00618
• Device Sequence Number: 10984454
• Product Code: LIT
• UDI-Device Identifier: 08717648208409
• UDI-Public: (01)08717648208409(17)200131(10)6080841
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K151317
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/23/2017

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: 01/31/2020
• Device Catalogue Number: 1013470-060
• Device Lot Number: 6080841
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 01/16/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/23/2017
• Supplement Report FDA Received Date: 01/23/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1