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

Catalog Number	1013469-100
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/20/2017
Type of Reportable Event	Serious Injury
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 is likely that during use the clearance between the guide wire lumen and the guide wire became reduced causing resistance.Further attempts to move the balloon dilatation catheter from the guide wire likely caused the devices to become frozen together.A review of the lot history records revealed no manufacturing nonconformities that would have contributed to this complaint.Additionally, a review of the complaint history of the reported lots revealed no other incidents.The investigation determined the reported difficulties and additional treatment was likely due to case circumstances.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 the procedure was to treat a lesion in the mildly calcified right superficial femoral artery.The 5.5mmx100mmx150 cm armada balloon dilatation catheter (bdc) was advanced over a 018 steelcore guide wire, and ballooning was performed.When attempting to remove the armada bdc, resistance was felt with the guide wire and the sheath.When trying to re-advance, the bdc could not be advanced on the guide wire.Both the bdc and guide wire could not be advanced past the sheath.Eventually, the bdc was pulled out of the patient enough to where the guide wire could be seen; and the guide wire had to be clamped to continue removing the bdc off the guide wire.Another guide wire and armada were used successfully complete the procedure without issue.There were no adverse patient effects.There was no clinically significant delay in the procedure.No additional information was provided.

• 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: 7003113
• Report Number: 2024168-2017-08691
• Device Sequence Number: 18863622
• Product Code: LIT
• UDI-Device Identifier: 08717648208317
• UDI-Public: 08717648208317
• Combination Product (Y/N): N
• Initial Reporter State: CT
• 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
• Report Date (Section B): 11/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/31/2019
• Device Catalogue Number: 1013469-100
• Device Lot Number: 5121541
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/20/2017
• Initial Report FDA Received Date: 11/06/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SHEATH: 5F 90CM ANSELGUIDE WIRE STEELCORE
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 71 YR
• Patient Weight: 84