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

Catalog Number	B2060-250
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/25/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.Evaluation summary: the device was not returned for analysis.The investigation determined the reported hub leak appears to be related to a potential product quality issue.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.The issue is being addressed per internal operating procedures.Abbott vascular will continue to trend the performance of these devices.
Event or Problem Description
It was reported that the procedure was to treat a de novo lesion located in the proximal femoral artery that was non tortuous, non calcified and 100% stenosed.Pre-dilatation was performed using the armada 35 6 x 250 mm percutaneous transluminal angioplasty catheter.The balloon was inflated to 8 atmospheres, but there was a leak between the shaft and connection cannula and pre-dilatation was unsuccessful.Another same size armada balloon was used, but the exact same issue was observed.The procedure was completed using another balloon.The patient was discharged from clinic after the treatment.There were no reported adverse patient effects 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: 7525600
• Report Number: 2024168-2018-03702
• Device Sequence Number: 16570097
• Product Code: LIT
• UDI-Device Identifier: 08717648155338
• UDI-Public: 08717648155338
• Combination Product (Y/N): N
• Initial Reporter Country: RS
• PMA/510(K) Number: K111899
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 05/18/2018

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: 09/30/2018
• Device Catalogue Number: B2060-250
• Device Lot Number: 50524G1
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/25/2018
• Initial Report FDA Received Date: 05/18/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 78 YR
• Patient Weight: 83