MAUDE Adverse Event Report: AV-TEMECULA-CT ARMADA 35 PTA CATHETER; PERIPHERAL DILATATION CATHETER

Catalog Number	B1080-060
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/31/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.Evaluation summary: visual, dimensional and functional inspections were performed on the returned device.The reported difficulty was confirmed.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that contributed to this event.Additionally, a review of the complaint history revealed no other incidents.It is likely that the balloon folds and profile dimensions became compromised after the first inflation and removal.Based on the information reviewed and analysis of the returned device, the reported difficulties appear to be related to case circumstances.There is no indication of a product quality issue with respect to manufacture, design or labeling.
Event or Problem Description
It was reported the procedure was to treat a lesion in the heavily calcified right common iliac.The 8mm x 60mm armada 35 balloon dilatation catheter (bdc) was advanced without issue for pre-dilatation.After pre-dilation was performed during removal, resistance was felt with the introducer sheath.The bdc and introducer sheath were removed as a single device.There were no adverse patient effects and there was no clinically significant delay during the procedure.No additional information was provided.

• Brand Name: ARMADA 35 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: 7286795
• Report Number: 2024168-2018-01286
• Device Sequence Number: 2273893
• Product Code: LIT
• UDI-Device Identifier: 08717648154874
• UDI-Public: 08717648154874
• 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
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 02/21/2018

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: 11/30/2020
• Device Catalogue Number: B1080-060
• Device Lot Number: 70613G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/06/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/01/2018
• Initial Report FDA Received Date: 02/21/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1