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

Catalog Number	B1050-080
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/14/2016
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.The device is expected to be returned for evaluation.It has not yet been received.A follow up report will be submitted with all relevant information.
Event or Problem Description
It was reported that during a percutaneous transluminal intervention procedure to treat a 75% stenosed lesion in the non-tortuous proximal superficial femoral artery (sfa), a 5.0 mm x 80 mm x 80 cm armada 35 ll balloon dilatation catheter (bdc) was advanced and inflated without difficulty, completing dilatation.When attempting to deflate the balloon, it was difficult to deflate and was consequently difficult to remove from the vessel.The balloon was able to be completely deflated after multiple deflation attempts and several minutes of aspiration using the same inflation device.The procedure was completed without complications.There were no adverse patient effects and no occurrence of a clinically significant delay.No additional information was provided.
Additional Manufacturer Narrative
(b)(4).The device was not returned for analysis.Without having the device to examine, the investigation was unable to determine a conclusive cause for the reported deflation difficulty resulting in difficulty removing.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 did not indicate a lot specific product issue.Based on the information reviewed, there is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

• 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: 6071506
• Report Number: 2024168-2016-07481
• Device Sequence Number: 13524962
• Product Code: LIT
• UDI-Device Identifier: 08717648154621
• UDI-Public: (01)08717648154621(17)190930(10)60413G1
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K111899
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/22/2016

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: 09/30/2019
• Device Catalogue Number: B1050-080
• Device Lot Number: 60413G1
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 10/10/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/01/2016
• Supplement Report FDA Received Date: 11/22/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1