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

Catalog Number	B1060-020
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/20/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).It was not possible to perform a thorough analysis on the product because it was not returned to abbott vascular for investigation.There was no damage noted to the balloon catheter prior to use or leak noted during preparation, which suggests a product quality issue did not contribute to the reported difficulties.In this case, it is likely the balloon interacted with the heavily calcified lesion such that the balloon became damaged and subsequently ruptured.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 other incidents from this lot.The investigation determined the reported difficulties appear 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.The additional armada 35 (6x40 and 7x40) are filed under separate medwatch report numbers.
Event or Problem Description
It was reported that the procedure was to treat a de novo lesion located in the mid superficial femoral artery (sfa) that is ectatic with heavy calcification.No resistance was felt during advancement of the three armada 35 balloon dilatation catheters (bdc) (6x40mm, 6x20mm, and 7x40mm) individually to the lesion; however, they all ruptured during the first inflation at nominal pressure.A replacement bdc was used to complete the procedure.There were no adverse patient effects or clinically significant delay in the procedure reported.No additional information was provided.

• Brand Name: ARMADA 35 PTA CATHETER
• Common Device Name: PERIPHERAL DILATATION CATHETER
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• MDR Report Key: 6247511
• Report Number: 2024168-2017-00388
• Device Sequence Number: 16350897
• Product Code: LIT
• UDI-Device Identifier: 08717648154683
• UDI-Public: (01)08717648154683(17)180630(10)50127G1
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K111899
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 01/12/2017

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
• Operator of Device: Health Professional
• Device Expiration Date: 06/30/2018
• Device Catalogue Number: B1060-020
• Device Lot Number: 50127G1
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/20/2016
• Initial Report FDA Received Date: 01/12/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1