• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

AV-TEMECULA-CT ARMADA 35 PTA CATHETER PERIPHERAL DILATATION CATHETER Back to Search Results
Catalog Number B1070-080
Device Problems Off-Label Use (1494); Difficult to Remove (1528); Material Rupture (1546); Material Separation (1562); Improper or Incorrect Procedure or Method (2017)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 07/31/2018
Event Type  Injury  
Manufacturer Narrative
(b)(4). During processing of this complaint, attempts were made to obtain complete event, patient and device information. Above rated burst pressure, incorrect anatomy. The device is expected to be returned for evaluation. It has not yet been received. A follow up report will be submitted with all additional relevant information.
 
Event Description
It was reported that the procedure was performed to treat a target lesion in the brachial vein, with restenosis of 80%. A non-abbott guide wire was advanced and angiogram was performed. A non-abbott 4. 0 x 10 mm dilatation catheter was used first, then the 7. 0 x 80 mm armada 35 dilatation catheter was advanced. The balloon was inflated to 14 atmospheres (atm), and then inflated to 20 atm. The balloon ruptured circumferentially. During balloon removal, resistance was noted with the non-abbott guide wire. Force was applied and upon removal, it was noted that a portion of the balloon remained in the patient. The separated segment was pushed back into the brachial vein and a cut-down procedure was performed to remove the segment. All portions of the armada 35 were removed. No additional information was provided.
 
Manufacturer Narrative
(b)(4). Visual analysis was performed on the returned device. The reported balloon rupture and separation was confirmed. The difficulty removing was not tested due to the condition of the device. A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event. Additionally, a review of the complaint history identified no other similar incidents from this lot. Per the armada 35 instruction for use (ifu), the device is intended for dilatation of lesions in specific arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. Additionally, inflation in excess of the rated burst pressure (rbp) may cause the balloon to rupture. It is likely that inflating the balloon above rbp contributed to the balloon rupture. The investigation determined that the reported difficulties were due to case circumstances. There is no indication of a product quality issue with respect to the design, manufacture or labeling of the device.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameARMADA 35 PTA CATHETER
Type of DevicePERIPHERAL DILATATION CATHETER
Manufacturer (Section D)
AV-TEMECULA-CT
abbott vascular
26531 ynez road
temecula CA 92591 4628
MDR Report Key7811731
MDR Text Key118086316
Report Number2024168-2018-06569
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
PMA/PMN Number
K111899
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Remedial Action Other
Type of Report Initial,Followup
Report Date 09/11/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/23/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date06/30/2021
Device Catalogue NumberB1070-080
Device Lot Number80102G1
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/24/2018
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/06/2018
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 08/23/2018 Patient Sequence Number: 1
-
-