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

Catalog Number	B2060-100
Medical Device Problem Codes	Material Rupture (1546); Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/10/2019
Type of Reportable Event	Serious Injury
Additional 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 revealed no manufacturing nonconformities that would have contributed to this complaint.Based on review of the similar incidents, there is no indication of a lot specific issue.The investigation was unable to determine a conclusive cause for the reported balloon rupture and balloon separation.There is no indication of a product quality issue with respect to manufacture, design or labeling of the device.
Event or Problem Description
It was reported that the procedure was performed to treat a calcified lesion in the superficial femoral artery.A 6.0x100mm armada 35 percutaneous transluminal angioplasty (pta) catheter was advanced to the target lesion without resistance.The device was then inflated twice to an unspecified pressure.During the third inflation below the nominal rated burst pressure, the balloon ripped/ruptured, and the distal portion of the balloon with the marker separated from the pta catheter.The proximal portion of the pta catheter was withdrawn from the patient anatomy without resistance, and a snare was used remove the separated balloon material from the patient anatomy.It was confirmed that no pieces of the pta catheter remained in the patient anatomy.The procedure concluded after the pta catheter was removed and no further treatment was provided.There was no adverse patient sequela.There was a reported delay in the procedure to snare the separated balloon; however, the delay was not clinically significant.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: 8298341
• Report Number: 2024168-2019-00772
• Device Sequence Number: 2462768
• Product Code: LIT
• UDI-Device Identifier: 08717648155291
• UDI-Public: 08717648155291
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K111899
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 02/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/31/2021
• Device Catalogue Number: B2060-100
• Device Lot Number: 80509G1
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/11/2019
• Initial Report FDA Received Date: 02/01/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention