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

Catalog Number B2070-040

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 11/08/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4). Evaluation summary: visual analysis was performed on the returned device. The reported balloon rupture and separation were confirmed. The difficulty to remove 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. The investigation determined that the reported difficulties and subsequent treatment was due to case circumstances. There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

Manufacturer Narrative

(b)(4). Internal file number - (b)(4): during processing of this complaint, attempts were made to obtain complete event, patient and device information. The device was received. The investigation is not yet complete. A follow-up report will be submitted with all additional relevant information.

Event Description

It was reported that the procedure was to treat a lesion in the heavily calcified iliac artery. A 7. 0 x 40 mm armada 35 percutaneous transluminal angioplasty (pta) catheter was advanced to the lesion with no resistance felt. The balloon ruptured at the 5th inflation of the balloon at 10 atmospheres, at contact with the atheroma plaque. The pta catheter could not be retracted through the guiding catheter and the distal shaft of the pta catheter separated. A cut down procedure was performed at the humeral artery to extract the distal shaft of the pta catheter. A new unspecified balloon catheter was used to successfully complete 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: 7072034
• MDR Text Key: 109564959
• Report Number: 2024168-2017-09280
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K111899
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig

Reporter Occupation

• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 01/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 04/30/2020
• Device Catalogue Number: B2070-040
• Device Lot Number: 61125G1
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 11/27/2017
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 01/04/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 11/30/2017 Patient Sequence Number: 1