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

Catalog Number	B1070-100
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/28/2018
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.Guide wire: terumo.Sheath: fortress 6 fr crossover.Evaluation summary: visual analysis was performed on the returned device.The reported balloon rupture and separation were confirmed.The difficulty removing was not tested due to the condition of the device.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 from this lot.The investigation determined that the reported difficulties and subsequent patient effects were due to case circumstances.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.
Event or Problem Description
It was reported that the procedure was to treat a de novo lesion located in the mid femoral artery that was mildly tortuous, heavily calcified and 80% stenosed.The armada 35 percutaneous transluminal angioplasty catheter was advanced with success however the balloon ruptured during the first inflation at 8 atmospheres due to excessive calcification in the treatment area.During removal of the delivery system with slight resistance, it was observed that 80 cm came out of the sheath in the patient and the proximal 10-12 cm of the system was still in crossover position in the treated area.The delivery system broke in two pieces in the patient.A snare device was used to retrieve the separated segment.This was done with success and no adverse patient effects and it was confirmed nothing was left in the patient.There was a clinically significant delay of 90 minutes and an extra 5000 units of heparin was given to patient.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: 7447182
• Report Number: 2024168-2018-02925
• Device Sequence Number: 1768511
• Product Code: LIT
• UDI-Device Identifier: 08717648154812
• UDI-Public: 08717648154812
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: K111899
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 04/20/2018

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: 11/30/2020
• Device Catalogue Number: B1070-100
• Device Lot Number: 70623G1
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/28/2018
• Initial Report FDA Received Date: 04/20/2018
• 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