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

Catalog Number	B2050-040
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/02/2017
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.(b)(4).Visual, dimensional and functional analysis was performed on the returned device.The reported deflation issue was not confirmed.Additionally, a review of the complaint history did not suggest a lot specific product issue.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 calcified total occlusion in the non-tortuous superficial femoral artery (sfa).A 5.0mmx40mmx135cm armada 35 balloon dilatation catheter (bdc) was unpackaged and prepped with a 50/50 contrast mix outside of the patient without difficulty.The armada 35 bdc was then advanced without difficulty.The balloon was inflated to nominal pressure without issue.When attempting to deflate the armada 35 balloon, the balloon failed to deflate and, consequently, was unable to be removed from the vessel.Surgical intervention was planned for deflation of the balloon, however, the balloon was re-inflated past its rated burst pressure, then deflation was re-attempted; with negative pressure drawn for 2 minutes, the balloon was slow to deflate, but was able to be completely deflated and withdrawn without the need for intervention.Another unspecified armada bdc was used to complete dilatation.There were no adverse patient effects.No additional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: 6675715
• Report Number: 2024168-2017-05505
• Device Sequence Number: 18846445
• Product Code: LIT
• UDI-Device Identifier: 08717648155178
• UDI-Public: (01)08717648155178(17)191031(10)60509G1
• Combination Product (Y/N): N
• Initial Reporter State: WV
• 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): 06/28/2017

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: 10/31/2019
• Device Catalogue Number: B2050-040
• Device Lot Number: 60509G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/20/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/07/2017
• Initial Report FDA Received Date: 06/28/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 70 YR
• Patient Weight: 108