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

Catalog Number B2060-060

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 04/05/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4). During processing of this complaint, attempts were made to obtain complete event, patient and device information. The incident information was reviewed; however, the product was not returned to abbott vascular 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 identified no other similar incidents reported from this lot. The investigation was unable to determine a conclusive cause for the reported balloon rupture. The reported difficulty removing the device causing the balloon separation appears to be related to circumstances of the procedure. There is no indication of a product quality issue with respect to manufacture, design or labeling of the device.

Event Description

It was reported that procedure was to treat a lesion in a heavily calcified, 80% stenosed, right superficial femoral artery. A 6 x 60 mm armada 35 percutaneous transluminal angioplasty (pta) catheter was advanced to the lesion without resistance. The balloon was inflated to 10 atmospheres, but on the second inflation the balloon ruptured before reaching nominal pressure. During removal of the pta catheter from the anatomy, the balloon caught on the edge of the unspecified 6f short introducer sheath and a portion of the balloon separated from the shaft. The pta catheter was removed from the anatomy. The 6f short introducer sheath was removed from the anatomy and replaced with a longer introducer sheath in an unsuccessful attempt to capture the balloon fragment. A cut down procedure was performed to remove the balloon fragment from the anatomy. The procedure was completed with the successful deployment of an unspecified stent implant. 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: 7459268
• MDR Text Key: 106464855
• Report Number: 2024168-2018-03049
• Device Sequence Number: 1
• Product Code: LIT
• 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

• Remedial Action: Other
• Type of Report: Initial
• Report Date: 04/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/25/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 04/30/2021
• Device Catalogue Number: B2060-060
• Device Lot Number: 71110G1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 04/05/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2017
• 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: 04/25/2018 Patient Sequence Number: 1

Treatment

INTRODUCER SHEATH: 6F SHORT SHEATH