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

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.

• 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
• MDR Report Key: 7811731
• MDR Text Key: 118086316
• Report Number: 2024168-2018-06569
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• PMA/PMN Number: K111899
• Number of Events Reported: 1
• 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 Received: 08/23/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2021
• Device Catalogue Number: B1070-080
• Device Lot Number: 80102G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/24/2018
• Date Manufacturer Received: 09/06/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 50 YR