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

Catalog Number	B1140-040
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/03/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.(b)(4).The device was not returned for analysis.It is likely that the challenging anatomical conditions resulted in the user inflating the balloon over the rbp in the attempt to open the vessel.As result, the rupture occurred causing a portion of the balloon to separate.It should be noted that the armada 35 instruction for use, states: inflation in excess of the rated burst pressure may cause the balloon to rupture.The lot history record (lhr) for this product could not be reviewed and a similar incident query could not be performed because the product was not returned for evaluation and the lot number was not reported.The investigation determined that the reported difficulties and additional treatment to remove the balloon fragment appear to be 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 that the procedure was to treat a restenosed lesion located in the inferior vena cava (ivc) with chronic total occlusion.Resistance was not felt as a 14 x 40 mm armada 35 balloon dilatation catheter (bdc) was advanced to the lesion and it crossed successfully.The balloon was inflated past the rated burst pressure (rbp) to 12 atmospheres in order to open the vessel; however, the balloon ruptured without opening the vessel.A piece of the balloon detached from the bdc when it ruptured.A snare device was used to retrieve the piece of balloon and it was confirmed that no balloon fragments remained in the anatomy.A non-abbott balloon was used to successfully treat the lesion.The patient outcome was good.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: 6274886
• Report Number: 2024168-2017-00663
• Device Sequence Number: 223972
• Product Code: LIT
• UDI-Device Identifier: 08717648155024
• UDI-Public: (01)08717648155024
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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): 01/24/2017

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 Catalogue Number: B1140-040
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/12/2017
• Initial Report FDA Received Date: 01/24/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 68 YR