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

Catalog Number B1100-040

Device Problems Detachment Of Device Component (1104); Material Rupture (1546); Improper or Incorrect Procedure or Method (2017)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/06/2017

Event Type  Injury  

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 for this product could not be reviewed and a similar incident query could not be performed because the product was not returned 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 Description

It was reported that the procedure was to treat a lesion with chronic total occlusion located in common femoral vein that was restenosed.Resistance was not felt as a 10 x 40 mm armada 35 balloon dilatation catheter (bdc) was advanced to the lesion and crossed successfully.The balloon was inflated to nominal but the vessel did not open; therefore, the balloon was inflated to the rated burst pressure (rbp).The vessel remained unopened at rbp, so the balloon was inflated above rbp to 18 atmospheres.The balloon ruptured at 18 atmospheres without opening the vessel and a piece of the balloon detached from the bdc.A snare device was used to retrieve the piece of balloon and it was confirmed that no balloon fragments remained in the anatomy.The procedure concluded without further treatment to the patient.No additional information was provided.

• Brand Name: ARMADA 35 PTA CATHETER
• Type of Device: PERIPHERAL DILATATION CATHETER
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• Manufacturer (Section G): ABBOTT VASCULAR, TEMECULA, CA USA REG# 2024168; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• Manufacturer Contact: connie speck ; abbott vascular; 26531 ynez road; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 6274534
• MDR Text Key: 65664329
• Report Number: 2024168-2017-00658
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 08717648154942
• UDI-Public: (01)08717648154942
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K111899
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 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
• Device Operator: Health Professional
• Device Catalogue Number: B1100-040
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/12/2017
• Initial Date FDA Received: 01/24/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 26 YR