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)

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.The device was not returned for analysis.It is likely that the rupture occurred due to interaction with the lesion site.The separation during removal likely occurred when removing the catheter and the ruptured balloon material caught on the introducer sheath.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 revealed no other incidents.The investigation determined that the reported difficulties and additional treatment to remove the balloon material appears 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 moderately tortuous and moderately calcified lesion in the right subclavian vein.A 7x40mm armada 35 balloon catheter was prepped per the instructions for use.The balloon catheter was advanced for post-dilatation; however, the balloon ruptured during the third inflation at nominal pressure.The balloon separated into two pieces and became caught.The patient was sent to surgery to successfully remove the balloon material.The patient is doing well.No additional information was provided.

Manufacturer Narrative

(b)(4).

Event Description

Subsequent to the previously filed report a user facility medwatch report was received that states: event desc: angioplasty being performed.Balloon was inside vessel and balloon ruptured.Radiologist unable to remove device and pt.Was taken to surgery for removal.Device usage problem: device malfunction - that is, the device did not do what it was supposed to do.

• 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: 6665066
• MDR Text Key: 78348166
• Report Number: 2024168-2017-05329
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 08717648154782
• UDI-Public: (01)08717648154782(17)200831(10)70322G1
• 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,Followup
• Report Date: 07/21/2017

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 Expiration Date: 08/31/2020
• Device Model Number: B1070-040
• Device Catalogue Number: B1070-040
• Device Lot Number: 70322G1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/14/2017
• Initial Date FDA Received: 06/23/2017
• Supplement Dates Manufacturer Received: 07/19/2017
• Supplement Dates FDA Received: 07/21/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2017
• 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: 79 YR
• Patient Weight: 84