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

Catalog Number B2070-040

Device Problems Material Rupture (1546); Material Separation (1562)

Patient Problem Vessel Or Plaque, Device Embedded In (1204)

Event Date 06/21/2018

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.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 appear to be due to case circumstances.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.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 an 80% stenosed lesion located in the tibial artery.The 7 x 40 mm armada 35 balloon catheter ruptured transversely upon inflation.After removal of the balloon catheter from the anatomy it was observed that the tip of the catheter had separated from the catheter and remained in the patient.A stent was used to crush the separated tip against the vessel wall.As this was the end of the procedure no further treatment was performed.No additional information was provided.

Manufacturer Narrative

Internal file number - (b)(4).Correction: the "date received by manufacturer" was filed incorrectly on the initial medwatch report as 06/28/2018, but should have been 06/26/2018.

• 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: 7675235
• MDR Text Key: 113587155
• Report Number: 2024168-2018-05211
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 08717648155352
• UDI-Public: 08717648155352
• 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: Risk Manager
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 07/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/10/2018
• 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: B2070-040
• Device Lot Number: 80105G1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/16/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/2018
• 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: 61 YR
• Patient Weight: 104