MAUDE Adverse Event Report: AV-TEMECULA-CT ARMADA 18 PTA CATHETER; PERIPHERAL DILATATION CATHETER

Catalog Number	1013468-100
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/05/2018
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.Visual and functional inspection was performed on the returned device.The reported leak was confirmed.Additionally, this lot has an exception and similar incidents associated with this failure mode.The investigation determined the reported leak appears to be related to a potential product quality issue.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 performed to treat a lesion in the superficial femoral artery (sfa) with mild calcification.A 5.0 x 100 mm armada balloon dilatation catheter (bdc) was advanced to the sfa.During the first inflation, the balloon was inflated to 10 atmospheres when it could not hold pressure.A leak in the distal portion of the strain relief was observed.The bdc was removed and replaced with an unspecified balloon catheter to successfully complete the procedure.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.

• Brand Name: ARMADA 18 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: 7969515
• Report Number: 2024168-2018-07931
• Device Sequence Number: 11206092
• Product Code: LIT
• UDI-Device Identifier: 08717648208201
• UDI-Public: 08717648208201
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K151317
• 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): 10/16/2018

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: 09/30/2020
• Device Catalogue Number: 1013468-100
• Device Lot Number: 7040541
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/10/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/05/2018
• Initial Report FDA Received Date: 10/16/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 63 YR
• Patient Weight: 89