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

Catalog Number	B2070-150
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/13/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device was not returned for analysis.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 of the reported lot revealed no other incidents.Based on the information reviewed, there is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.The investigation determined that the reported balloon rupture appears to be related to circumstances of the procedure.
Event or Problem Description
It was reported the procedure was to treat a moderately calcified lesion in the superficial femoral artery (sfa).The 6.0 x 200 mm armada 18 balloon catheter was advanced to the target lesion for pre-dilatation and was inflated and deflated successfully.The device was withdrawn without issues from the patient anatomy.The 7.0 x 150 mm armada 35 was advanced to the target lesion for additional pre-dilatation; however, the balloon ruptured at 8 atmospheres during the first inflation.The armada 18 balloon was to be used for post dilatation; however, it could not be re-inserted into the sheath due to the balloon folds.A new armada balloon catheter was used to complete the procedure successfully.There was no adverse patient effect and no clinically significant delay in the procedure.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: 6080822
• Report Number: 2024168-2016-07637
• Device Sequence Number: 13745391
• Product Code: LIT
• UDI-Device Identifier: 08717648155406
• UDI-Public: (01)08717648155406(17)190930(10)60405G1
• Combination Product (Y/N): N
• Initial Reporter State: OK
• 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
• Report Date (Section B): 11/04/2016

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: 09/30/2019
• Device Catalogue Number: B2070-150
• Device Lot Number: 60405G1
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/27/2016
• Initial Report FDA Received Date: 11/04/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 80 YR