MAUDE Adverse Event Report: AV-TEMECULA-CT ARMADA 18 PTA CATHETER; PERIPHERAL DILATATION CATHETER

Catalog Number 1013469-150

Device Problems Detachment Of Device Component (1104); Difficult to Remove (1528); Material Rupture (1546); Stretched (1601)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/21/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Concomitant medical products: guide wire: steelcore.018, sheath: cook ansel 6fr.The device was received.Investigation is not yet complete.A follow up report will be submitted with all relevant information.

Event Description

It was reported that the procedure was to treat a lesion located in the extremely heavily calcified right superficial femoral artery.The 5.5 x 150 mm armada 18 balloon catheter was inflated three times for pre-dilatation of the lesion.A cutting balloon was advanced and inflated at the heavily calcified lesion and the balloon ruptured.The same armada 18 balloon was re-advanced and inflated one time to between 6 and 8 atmospheres, at which time the balloon ruptured.Resistance was felt during retraction of the balloon catheter through the 6fr sheath and during retraction the ruptured balloon caught in the sheath and the balloon material separated.Additionally, the distal end of the shaft elongated and stretched for a least 6 inches due to pulling hard during retraction.The separated segment of balloon material was removed along with the balloon catheter leaving nothing in the patient.The procedure continued on successfully using the same 6fr sheath and new devices.No adverse patient effects or clinically significant delay in the procedure were reported.No additional information was provided.

Manufacturer Narrative

(b)(4).Evaluation summary: visual analysis inspections were performed on the returned device.The reported balloon rupture, balloon separation and stretching was confirmed.The reported resistance with the introducer sheath could not be tested due to the condition of the returned device.A review of the lot history record revealed no manufacturing nonconformities that would have contributed to this complaint.Additionally, a review of the complaint history identified no similar incidents from this lot.The investigation determined the reported difficulties appears to be related to circumstances of the procedure.Based on the information reviewed, there is no indication of a product quality issue with respect to manufacture, design or labeling.

• Brand Name: ARMADA 18 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): CLONMEL, IRELAND REG# 9616693; 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: 6711047
• MDR Text Key: 80121262
• Report Number: 2024168-2017-05854
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K151317
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 09/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2019
• Device Catalogue Number: 1013469-150
• Device Lot Number: 6050441
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/10/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/21/2017
• Initial Date FDA Received: 07/13/2017
• Supplement Dates Manufacturer Received: 09/05/2017
• Supplement Dates FDA Received: 09/12/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2016
• 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 Age: 75 YR
• Patient Weight: 49