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

Catalog Number B1080-040

Device Problem Material Rupture (1546)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/25/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.(b)(4).It is indicated that the complaint device is not returning for evaluation; therefore, a failure analysis of the device could not be completed.The analysis of this complaint was an assessment of the information provided to abbott vascular, the manufacturing records, and complaint history.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot.Additionally, a review of the complaint history identified no other incidents from this lot.The investigation determined that the reported balloon rupture appears to be due to case circumstances.Based on the reviewed information, there is no indication the issue was caused by, or related to the design, manufacture, or labeling of the device.

Event Description

It was reported that the procedure was to treat a 75% restenosed, heavily calcified shunt.The 8.0mmx40mmx80cm armada 35 balloon dilatation catheter (bdc) was unpackaged and prepped before use without issue.The bdc was advanced to the target lesion without issue; however, the balloon ruptured at 12 atmospheres (atm) and the bdc was removed without issue.There were no reported adverse patient effects and no reported clinically significant delay in the procedure.A new armada 35 bdc was used to successfully complete the procedure.There was 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: 5315912
• MDR Text Key: 34608719
• Report Number: 2024168-2015-07808
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K111899
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 12/21/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2018
• Device Catalogue Number: B1080-040
• Device Lot Number: 50518G1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/26/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2015
• 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