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

Catalog Number	B2060-200
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/30/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device was received.Investigation is not yet complete.A follow up report will be submitted with all relevant information.The additional armada device is filed under a separate medwatch report.
Event or Problem Description
It was reported that the procedure was to treat a left superficial femoral artery.The 6.0x200 mm armada 35 balloon dilatation catheter (bdc) was advanced without issue to the target lesion.The balloon ruptured at 4 atmospheres during the first inflation.The bdc was remove without issue and another 6.0x200 mm armada 35 bdc was advanced without issue and it also ruptured at 4 atmospheres during the first inflation.An unspecified bdc was used to complete the procedure.There were no adverse patient effects and no reported clinically significant delay in the procedure.No additional information was provided.
Additional Manufacturer Narrative
Internal file number - (b)(4).Evaluation summary: a visual inspection was performed.The reported balloon rupture was confirmed.The balloon catheter was sent to scanning electron microscopy (sem) for further analysis.Sem results concluded the balloon failure initiation may be attributed to mechanical damage to the outer surface.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.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

• 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: 7283401
• Report Number: 2024168-2018-01240
• Device Sequence Number: 1994549
• Product Code: LIT
• UDI-Device Identifier: 08717648155321
• UDI-Public: 08717648155321
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/14/2018

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: 07/31/2020
• Device Catalogue Number: B2060-200
• Device Lot Number: 70206G1
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 02/06/2018
• Initial Date Received by Manufacturer: 01/30/2018
• Supplement Date Received by Manufacturer: 03/05/2018
• Initial Report FDA Received Date: 02/20/2018
• Supplement Report FDA Received Date: 03/14/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 76 YR
• Patient Weight: 96