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

Model Number B1070-040

Device Problems Detachment Of Device Component (1104); Difficult to Remove (1528); Material Rupture (1546); Improper or Incorrect Procedure or Method (2017)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/09/2017

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 balloon rupture, difficulty removing and separation were the result of inflating the balloon over the rbp.The instructions 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 appear to be user related.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.The additional armada devices are filed under separate medwatch reports.

Event Description

It was reported that procedure was to treat a right arm fistula with 80% stenosis.A 6mm x 20mm armada 35 balloon dilatation catheter (bdc) was advanced to the target lesion.During the first inflation, to 24 atmospheres (atm) the balloon ruptured (rbp).The armada bdc was replaced with another same size armada bdc and during the first inflation to 24 atm the balloon ruptured.A 7mm x 40mm armada bdc was advanced to the target lesion.During the third inflation, to 24 atm the balloon ruptured.The 7mm x 40mm armada bdc was difficult to remove from the sheath.The devices were removed together as a single unit.Upon removal of the device, it was noted that a portion of the balloon along with part of the inner member with the balloon marker remained in the patient anatomy.An attempt to snare the separated portion of the balloon was unsuccessful, a cut down was performed to remove the separated balloon.No additional treatment was required; the procedure was complete at this time.The patient is stable.There was no adverse patient sequela and no clinically significant delay in the procedure.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): EL COYOL, COSTA RICA REG# 3009031392; 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: 6684839
• MDR Text Key: 79025926
• Report Number: 2024168-2017-05622
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 08717648154782
• UDI-Public: (01)08717648154782
• 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: 07/03/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/03/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: B1070-040
• Device Catalogue Number: B1070-040
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/15/2017
• 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: 29 YR
• Patient Weight: 84