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

Catalog Number B1070-040

Device Problems Difficult to Remove (1528); Material Rupture (1546)

Patient Problem Thrombosis (2100)

Event Date 11/13/2017

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 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 non-calcified fistula cephalic vein.A 7.0 x 40mm armada 35 balloon dilatation catheter was inflated once at 15 atmospheres and ruptured.The balloon was attempted to be removed as a single unit along with the sheath but would not come out.However, after 2 hours an 11fr sheath was inserted above the balloon and was snared successfully but with resistance felt.A tear was found on the balloon after removal.During the procedure the 11fr sheath made a hole in the fistula requiring sutures which will be removed in a week.Patient experienced some blood loss and was admitted overnight.Another device was used to successfully complete the procedure.No additional information was provided.

Manufacturer Narrative

(b)(4).Evaluation summary: a visual inspection was performed and the reported material rupture was confirmed.Additionally, the shaft was found separated distal to the strain relief tubing and the proximal marker was loose on the inner member and was located at the distal marker.Follow-up with the site determined that the separation was caused by intentional manipulation in order to retrieve the balloon via the 11fr sheath.The reported difficulty removing from the sheath could not be performed due to device condition.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.

Manufacturer Narrative

(b)(4).

• 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: 7095583
• MDR Text Key: 94112379
• Report Number: 2024168-2017-09486
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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,Followup
• Report Date: 08/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2021
• Device Catalogue Number: B1070-040
• Device Lot Number: 70926G1
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 12/19/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/01/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2017
• 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
• Treatment: SHEATH: 11FR
• Patient Outcome(s): Hospitalization; Required Intervention