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

Catalog Number B1060-040

Device Problems Kinked (1339); Difficult to Remove (1528); Material Rupture (1546); Torn Material (3024)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/13/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).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 to treat a de novo lesion in the non-tortuous, mildly calcified, popliteal artery with a 6.00 x 40 mm armada 35 armada 35 percutaneous transluminal angioplasty (pta) catheter.The pta catheter was advanced to the lesion and upon the first inflation the balloon ruptured, tore, and kinked.During removal from the anatomy, the pta catheter would no longer fit into the 5f sheath.The 5f sheath was removed and a 6f sheath was carefully advanced over the pta catheter.The pta catheter was removed from the anatomy together with the 6f sheath.The procedure was stopped at that point.No additional information was provided.

Manufacturer Narrative

(b)(4).A visual inspection was performed and the reported balloon rupture and kink were confirmed.The reported difficulty to remove and balloon tear were unable to be confirmed due to the condition of the device.Additionally, the outer and inner member were separated.Follow-up with the site was performed and identified that the portion with the hub was intentionally removed to facilitate the removal of the 5f sheath and the advancement of the 6f sheath over 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 reported from this lot.The investigation was unable to determine a conclusive cause for the reported balloon rupture.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

Event Description

Subsequent to filing the initial mdr, the following additional information was received: the pressure of the first inflation was about 4 atmospheres (atm) when the balloon ruptured, tore, and the shaft kinked where the proximal end of the balloon is attached.No additional information 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: 7635838
• MDR Text Key: 112272582
• Report Number: 2024168-2018-04987
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K111899
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 08/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/25/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2021
• Device Catalogue Number: B1060-040
• Device Lot Number: 71013G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/13/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/30/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2017
• 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